Systems for wearable infusion port and associated pump

ABSTRACT

A pump for delivering a fluid includes a pump housing that defines at least one reservoir having a circumferentially open first end, a circumferentially closed second end and a chamber to receive the fluid. The pump includes a plunger assembly having at least one plunger arm and a cannula fluidly coupled to the plunger arm to dispense the fluid from the pump. The plunger arm is receivable within the first end of the reservoir, and the at least one plunger arm defining an internal conduit to receive the fluid from the at least one fluid reservoir. The internal conduit is fluidly coupled to the cannula. The plunger assembly is movable in a first direction relative to the pump housing to advance the plunger arm within the fluid reservoir to dispense the fluid from the fluid reservoir out of the pump via the cannula.

FIELD

Embodiments of the subject matter described herein relate generally tomedical devices, such as a wearable infusion port and a pump associatedwith the wearable infusion port for providing the infusion port with afluid. More particularly, embodiments of the subject matter relate tosystems that provide a wearable infusion port that is coupled to a userto provide an infusion therapy for an extended period of time, and apump that interfaces with the wearable infusion port to provide theinfusion port with the fluid.

BACKGROUND

Certain diseases or conditions may be treated, according to modernmedical techniques, by delivering a medication or other substance to thebody of a user, either in a continuous manner or at particular times ortime intervals within an overall time period. For example, diabetes iscommonly treated by delivering defined amounts of insulin to the user atappropriate times. Some common modes of providing insulin therapy to auser include delivery of insulin through manually operated syringes andinsulin pens.

The use of manually operated syringes and insulin pens requires a userto inject the insulin directly into their anatomy. Some users, however,are uncomfortable with injecting themselves directly with insulin. Inaddition, in certain instances, the user may need to directly injectinsulin multiple times over a course of a day. This results in the userbeing subjected to multiple injections, which may be uncomfortable forthe user. In addition, for users who require multiple doses of the fluidover the course of the day, multiple syringes are needed to provide thefluid for injection. It may be inconvenient for the user to carry themultiple syringes.

Accordingly, it is desirable to provide systems for a wearable infusionport, which enables a user to inject the fluid, such as insulin, intothe port, instead of their anatomy. Moreover, it is desirable to providesystems for a wearable infusion port, which enables the user to reduce anumber of times their anatomy is pierced to deliver the infusiontherapy. In addition, it is desirable to provide a pump to supply thewearable infusion port with the fluid, such as insulin, which is capableof containing a quantity of fluid that is greater than one dose.Furthermore, other desirable features and characteristics will becomeapparent from the subsequent detailed description and the appendedclaims, taken in conjunction with the accompanying drawings and theforegoing technical field and background.

BRIEF SUMMARY

The techniques of this disclosure generally relate to systems thatprovide a wearable infusion port for infusing a fluid into an anatomy,such as insulin, and a pump associated with the wearable infusion portfor supplying the wearable infusion port with a quantity of the infusionfluid.

According to various embodiments, a wearable infusion port for infusinga fluid is provided. The wearable infusion port includes a first housingthat defines an inlet port to receive the fluid, and a second housingcoupled to the first housing. The second housing is to be coupled to ananatomy. The wearable infusion port includes a valve assembly fluidlycoupled to the inlet port to receive the fluid, and the valve assemblyis movable from a closed state to an opened state to dispense the fluid.The wearable infusion port further includes a cannula assembly extendingthrough the first housing and the second housing, and the cannulaassembly includes a cannula fluidly coupled to the valve assembly toreceive the fluid. The cannula is to be coupled to the anatomy to infusethe fluid into the anatomy. The wearable infusion port includes a flowsensor fluidly coupled to the inlet port and the cannula. The flowsensor is fluidly coupled upstream from the cannula to observe an amountof fluid received by the cannula.

Further provided is a wearable infusion port for infusing a fluid. Thewearable infusion port includes a first housing that defines an inletport to receive the fluid and a second housing coupled to the firsthousing. The second housing is to be coupled to an anatomy. The wearableinfusion port includes a valve assembly fluidly coupled to the inletport to receive the fluid, and the valve assembly is movable from aclosed state to an opened state to dispense the fluid. The wearableinfusion port includes a cannula assembly extending through the firsthousing and the second housing, and the cannula assembly includes acannula fluidly coupled to the valve assembly to receive the fluid. Thecannula is to be coupled to the anatomy to infuse the fluid into theanatomy. The wearable infusion port further includes a physiologicalcharacteristic sensor coupled to the first housing proximate an end ofthe first housing and spaced apart from the inlet port, and thephysiological characteristic sensor is to be coupled to the anatomy toobserve a physiological characteristic associated with the anatomy.

Also provided is a wearable infusion port for infusing a fluid. Thewearable infusion port includes a first housing that defines an inletport to receive the fluid, and a second housing coupled to the firsthousing. The second housing is to be coupled to an anatomy. The wearableinfusion port includes a valve assembly fluidly coupled to the inletport to receive the fluid. The valve assembly includes a valve housingand a shaft defining a shaft conduit downstream from the inlet port. Theshaft movable relative to the housing to move the valve assembly betweena closed state and an opened state to dispense the fluid. The wearableinfusion port includes a cannula assembly extending through the firsthousing and the second housing, the cannula assembly including a cannulafluidly coupled to the valve assembly to receive the fluid in the openedstate, the cannula to be coupled to the anatomy to infuse the fluid intothe anatomy.

According to various embodiments, also provided is a pump for deliveringa fluid. The pump includes a pump housing that defines at least onereservoir having a circumferentially open first end, a circumferentiallyclosed second end and a chamber defined between the first end and thesecond end to receive the fluid. The pump includes a plunger assemblyhaving at least one plunger arm and a cannula fluidly coupled to the atleast one plunger arm to dispense the fluid from the pump. The at leastone plunger arm is receivable within the first end of the at least onefluid reservoir, and the at least one plunger arm defining an internalconduit to receive the fluid from the at least one fluid reservoir. Theinternal conduit is fluidly coupled to the cannula. The plunger assemblyis movable in a first direction relative to the pump housing to advancethe at least one plunger arm within the at least one fluid reservoir todispense the fluid from the at least one fluid reservoir out of the pumpvia the cannula.

Further provided is a pump for delivering a fluid. The pump includes apump housing that defines at least one reservoir having acircumferentially open first end, a circumferentially closed second endand a chamber defined between the first end and the second end toreceive the fluid. The pump includes a plunger assembly having a plungerbase, at least one plunger arm and a cannula. The at least one plungerarm is coupled to a perimeter of the plunger base and the cannula iscoupled proximate a center of the plunger base. The at least one plungerarm is receivable within the first end of the at least one fluidreservoir, and the at least one plunger arm defines an internal conduitto receive the fluid from the at least one fluid reservoir. The internalconduit is fluidly coupled to a base conduit defined in the plungerbase, and the base conduit is fluidly coupled to the cannula. Theplunger assembly is movable in a first direction relative to the pumphousing to advance the at least one plunger arm within the at least onefluid reservoir to dispense the fluid from the at least one fluidreservoir out of the pump via the cannula.

Also provided is a pump for delivering a fluid. The pump includes a pumphousing that defines at least one reservoir having a circumferentiallyopen first end, a circumferentially closed second end and a chamberdefined between the first end and the second end to receive the fluid.The pump includes a plunger assembly having a plunger base, at least oneplunger arm and a cannula. The at least one plunger arm is coupled to aperimeter of the plunger base and the cannula is coupled proximate acenter of the plunger base. The at least one plunger arm is receivablewithin the first end of the at least one fluid reservoir, and the atleast one plunger arm defines an internal conduit to receive the fluidfrom the at least one fluid reservoir. The internal conduit is fluidlycoupled to a base conduit defined in the plunger base. The base conduitis fluidly coupled to the cannula. The plunger assembly is movable in afirst direction relative to the pump housing to advance the at least oneplunger arm within the at least one fluid reservoir to dispense thefluid from the at least one fluid reservoir out of the pump via thecannula. The pump also includes a lock system coupled to the pumphousing between the pump housing and the plunger base. The lock systemis movable to move the plunger assembly between a first, unlockedposition in which the plunger assembly is movable relative to the pumphousing to dispense the fluid and a second, locked position in which theplunger assembly is fixed relative to the pump housing.

This summary is provided to introduce a selection of concepts in asimplified form that are further described below in the detaileddescription. This summary is not intended to identify key features oressential features of the claimed subject matter, nor is it intended tobe used as an aid in determining the scope of the claimed subjectmatter. The details of one or more aspects of the disclosure are setforth in the accompanying drawings and the description below. Otherfeatures, objects, and advantages of the techniques described in thisdisclosure will be apparent from the description and drawings, and fromthe claims.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the subject matter may be derived byreferring to the detailed description and claims when considered inconjunction with the following figures, wherein like reference numbersrefer to similar elements throughout the figures.

FIG. 1 is a perspective view of an infusion system that includes awearable infusion port and a pump for dispensing a fluid into thewearable infusion port according to various teachings of the presentdisclosure;

FIG. 2 is a perspective view of the wearable infusion port of FIG. 1;

FIG. 3 is a partially exploded view of the wearable infusion port ofFIG. 1;

FIG. 4 is a cross-sectional view of the wearable infusion port of FIG.1, taken along line 4-4 of FIG. 2;

FIG. 4A is a bottom view of a first housing of the wearable infusionport of FIG. 1;

FIG. 5 is an exploded view of a valve assembly associated with thewearable infusion port of FIG. 1;

FIG. 5A is a perspective view of the valve assembly associated with thewearable infusion port of FIG. 1;

FIG. 5B is a rear perspective view of a rotor of the valve assembly ofFIG. 5;

FIG. 5C is a side perspective view of the valve assembly associated withthe wearable infusion port of FIG. 1;

FIG. 5D is a cross-sectional view of the valve assembly, taken alongline 5D-5D of FIG. 5C;

FIG. 5E is a bottom perspective view of an actuator shaft associatedwith the valve assembly;

FIG. 6 is a cross-sectional view of the valve assembly, taken along line6-6 of FIG. 5A, which illustrates the valve assembly in a closed statein accordance with various embodiments;

FIG. 7 is an exploded view of a cannula assembly associated with thewearable infusion port of FIG. 1;

FIG. 8 is an exploded view of a continuous glucose monitor assemblyassociated with the wearable infusion port of FIG. 1;

FIG. 9 is a cross-sectional view of the valve assembly, taken along line6-6 of FIG. 5A, which illustrates the valve assembly moving from theclosed state to an opened state in accordance with various embodiments;

FIG. 10 is a cross-sectional view of the valve assembly, taken alongline 6-6 of FIG. 5A, which illustrates the valve assembly moving in theopened state in accordance with various embodiments;

FIG. 11 is a perspective view of another wearable infusion port inaccordance with various embodiments;

FIG. 12 is an exploded view of the wearable infusion port of FIG. 11;

FIG. 13 is a cross-sectional view of the wearable infusion port of FIG.11, taken along line 13-13 of FIG. 11;

FIG. 13A is a bottom perspective view of a first housing associated withthe wearable infusion port of FIG. 11;

FIG. 14 is a perspective view of a valve assembly associated with thewearable infusion port of FIG. 11;

FIG. 15 is a detail view of the wearable infusion port, taken at 15 onFIG. 13, which illustrates the valve assembly in an opened state;

FIG. 16 is a detail view of the wearable infusion port, taken at 15 onFIG. 13, which illustrates the valve assembly in a closed state;

FIG. 17 is a perspective view of the wearable infusion port of FIG. 11,in which the first housing has been removed for clarity;

FIG. 18 is a cross-sectional view of the wearable infusion port and thepump of FIG. 1, which is taken along line 18-18 of FIG. 1;

FIG. 19 is a bottom view of the pump of FIG. 1 in accordance withvarious embodiments;

FIG. 20 is an exploded view of the pump;

FIG. 20A is a top perspective view of a plunger assembly associated withthe pump;

FIG. 20B is a side view of the plunger assembly associated with thepump;

FIG. 20C is a cross-sectional view of the plunger assembly, taken alongline 20C-20C of FIG. 20B, which illustrates conduits associated with theplunger assembly;

FIG. 21 is a partially cross-sectional view of the pump, taken alongline 21-21 of FIG. 1, which illustrates an advancement of a plungerassembly within a fluid reservoir associated with the pump;

FIG. 22 is a partially cross-sectional view of the pump, taken alongline 21-21 of FIG. 1, which illustrates the plunger assembly advanced toa second reservoir end of the fluid reservoir associated with the pumpto empty the fluid from the fluid reservoir;

FIG. 23 is a partially cross-sectional view of the pump, taken alongline 23-23 of FIG. 19, which illustrates the plunger assembly (and thepump) in the first, unlocked position; and

FIG. 24 is a partially cross-sectional view of the pump, taken alongline 23-23 of FIG. 19, which illustrates the plunger assembly (and thepump) in the second, locked position.

DETAILED DESCRIPTION

The following detailed description is merely illustrative in nature andis not intended to limit the embodiments of the subject matter or theapplication and uses of such embodiments. As used herein, the word“exemplary” means “serving as an example, instance, or illustration.”Any implementation described herein as exemplary is not necessarily tobe construed as preferred or advantageous over other implementations.Furthermore, there is no intention to be bound by any expressed orimplied theory presented in the preceding technical field, background,brief summary or the following detailed description.

Certain terminology may be used in the following description for thepurpose of reference only, and thus are not intended to be limiting. Forexample, terms such as “top”, “bottom”, “upper”, “lower”, “above”, and“below” could be used to refer to directions in the drawings to whichreference is made. Terms such as “front”, “back”, “rear”, “side”,“outboard”, and “inboard” could be used to describe the orientationand/or location of portions of the component within a consistent butarbitrary frame of reference which is made clear by reference to thetext and the associated drawings describing the component underdiscussion. Such terminology may include the words specificallymentioned above, derivatives thereof, and words of similar import.Similarly, the terms “first”, “second”, and other such numerical termsreferring to structures do not imply a sequence or order unless clearlyindicated by the context.

As used herein, the term “axial” refers to a direction that is generallyparallel to or coincident with an axis of rotation, axis of symmetry, orcenterline of a component or components. For example, in a cylinder ordisc with a centerline and generally circular ends or opposing faces,the “axial” direction may refer to the direction that generally extendsin parallel to the centerline between the opposite ends or faces. Incertain instances, the term “axial” may be utilized with respect tocomponents that are not cylindrical (or otherwise radially symmetric).For example, the “axial” direction for a rectangular housing containinga rotating shaft may be viewed as a direction that is generally parallelto or coincident with the rotational axis of the shaft. Furthermore, theterm “radially” as used herein may refer to a direction or arelationship of components with respect to a line extending outward froma shared centerline, axis, or similar reference, for example in a planeof a cylinder or disc that is perpendicular to the centerline or axis.In certain instances, components may be viewed as “radially” alignedeven though one or both of the components may not be cylindrical (orotherwise radially symmetric). Furthermore, the terms “axial” and“radial” (and any derivatives) may encompass directional relationshipsthat are other than precisely aligned with (e.g., oblique to) the trueaxial and radial dimensions, provided the relationship is predominantlyin the respective nominal axial or radial direction. As used herein, theterm “transverse” denotes an axis that crosses another axis at an anglesuch that the axis and the other axis are neither substantiallyperpendicular nor substantially parallel.

The following description relates to various embodiments of systems forwearable infusion ports, and a pump to supply fluid to a wearableinfusion port. The wearable infusion ports described herein enable auser to receive infusion therapy, such as insulin infusion therapy, overan extended period of time with a single injection site. The wearableinfusion port enables the user to receive infusion therapy withoutdirectly injecting their anatomy with a syringe or insulin pen, forexample. In addition, the pump is configured to interface with thewearable infusion port to supply the wearable infusion port with aquantity of the infusion fluid, such as insulin. The pump may also beconfigured as a patch pump, which may be coupled to the anatomy of auser via an adhesive patch for example.

It should be noted that while the wearable infusion port and the pumpare each described herein as being used to treat diabetes, embodimentsof the disclosed subject matter are not so limited. Accordingly, theinfused medication fluid is insulin in certain embodiments. Inalternative embodiments, however, many other fluids may be administeredthrough infusion such as, but not limited to, disease treatments, drugsto treat pulmonary hypertension, iron chelation drugs, pain medications,anti-cancer treatments, medications, vitamins, hormones, or the like.For the sake of brevity, conventional features and characteristicsrelated to infusion system operation, insulin pump and/or infusion setoperation, fluid reservoirs, and fluid syringes may not be described indetail here.

As used herein, the term module refers to any hardware, software,firmware, electronic control component, processing logic, and/orprocessor device, individually or in any combination, including withoutlimitation: application specific integrated circuit (ASIC), anelectronic circuit, a processor (shared, dedicated, or group) and memorythat executes one or more software or firmware programs, a combinationallogic circuit, and/or other suitable components that provide thedescribed functionality.

Embodiments of the present disclosure may be described herein in termsof functional and/or logical block components and various processingsteps. It should be appreciated that such block components may berealized by any number of hardware, software, and/or firmware componentsconfigured to perform the specified functions. For example, anembodiment of the present disclosure may employ various integratedcircuit components, e.g., memory elements, digital signal processingelements, logic elements, look-up tables, or the like, which may carryout a variety of functions under the control of one or moremicroprocessors or other control devices. In addition, those skilled inthe art will appreciate that embodiments of the present disclosure maybe practiced in conjunction with any number of systems, and that thesystems described herein is merely exemplary embodiments of the presentdisclosure.

For the sake of brevity, conventional techniques related to signalprocessing, data transmission, signaling, control, machine learningmodels, and other functional aspects of the systems (and the individualoperating components of the systems) may not be described in detailherein. Furthermore, the connecting lines shown in the various figurescontained herein are intended to represent example functionalrelationships and/or physical couplings between the various elements. Itshould be noted that many alternative or additional functionalrelationships or physical connections may be present in an embodiment ofthe present disclosure.

With reference to FIG. 1, FIG. 1 is a perspective view of an infusionsystem 100. In one example, the infusion system 100 includes a wearableinfusion port 102 and a pump 104. As will be discussed, the wearableinfusion port 102 may be coupled directly to a user to deliver atreatment fluid, such as insulin, to the body of the user. The pump 104may be coupled to the wearable infusion port 102 to supply the wearableinfusion port 102 with the treatment fluid, such as insulin. Withreference to FIGS. 2 and 3, the wearable infusion port 102 is shown. Thewearable infusion port 102 is generally rectangular or square, however,it will be understood that the wearable infusion port 102 may have anydesired shape. In one example, the wearable infusion port 102 includesan upper or first housing 110, a bottom or second housing 112, a valveassembly 114, a cannula assembly 116, a continuous glucose monitorassembly 118 and a control system 120. The wearable infusion port 102may be coupled to the user via an adhesive patch 122.

The first housing 110 and the second housing 112 may be composed of asuitable biocompatible material, including, but not limited to abiocompatible polymer-based material, which may be molded, printed,cast, etc. The first housing 110 and the second housing 112 aresubstantially rectangular or square, however, the first housing 110 andthe second housing 112 may have any desired shape. The first housing 110and the second housing 112 cooperate to substantially enclose the valveassembly 114, the cannula assembly 116, the continuous glucose monitorassembly 118 and the control system 120. With reference to FIGS. 4 and4A, the first housing 110 defines a receiving projection 130, a firstneedle port 132, a second needle port 134 and a coupling interface 136.

The receiving projection 130 receives a portion of the continuousglucose monitor assembly 118 for coupling the continuous glucose monitorassembly 118 to the first housing 110. Generally, the receivingprojection 130 extends inward, through a first surface 110 a of thefirst housing 110, toward the second housing 112. The receivingprojection 130 is shown as cylindrical (FIG. 4A), but may have anydesired shape. With brief reference to FIG. 4A, the receiving projection130 may include a cut-out 130 c, which cooperates with the portion ofthe continuous glucose monitor assembly 118 to couple the continuousglucose monitor assembly 118 to the first housing 110. The cut-out 130 cprovides clearance for an electrical connection between the electricalcontacts 380 and the circuit board 396. With reference back to FIG. 4,the first needle port 132 is defined through the first surface 110 a ofthe first housing 110, and enables a needless syringe, infusion pen orother device, such as the pump 104, to dispense fluid into the wearableinfusion port 102. The first needle port 132 is in fluid communicationwith the valve assembly 114 to provide the fluid received through thefirst needle port 132 to the valve assembly 114, as will be discussed.With brief reference to FIG. 4A, the first needle port 132 may besurrounded by a lip 132 a defined on the first housing 110, whichassists in coupling a portion of the valve assembly 114 to the firsthousing 110. With reference back to FIG. 4, the first needle port 132defines an inlet for the wearable infusion port 102. The second needleport 134 is defined in the first surface 110 a, and enables an insertiondevice, such as a needle or other device, to couple the cannula assembly116 to the anatomy. Thus, the second needle port 134 is in communicationwith the cannula assembly 116 to enable a portion of the cannulaassembly 116 to be coupled to the anatomy. Generally, the second needleport 134 is defined through the first surface 110 a so as to be spaced adistance apart from the first needle port 132 and the receivingprojection 130. In this example, with brief reference to FIG. 2, thesecond needle port 134 is defined adjacent to a first end 110 b of thefirst housing 110, and the receiving projection 130 is defined adjacentto a second end 110 c of the first housing 110, with the second end 110c opposite the first end 110 b. The second needle port 134 is definedgenerally along a center axis CA of the wearable infusion port 102. Byspacing the second needle port 134 from the receiving projection 130,the likelihood of insulin delivered by the cannula assembly 116affecting the continuous glucose monitor assembly 118 is reduced. Withbrief reference to FIG. 4A, the second needle port 134 may include acylindrical portion 134 a defined about a perimeter of the second needleport 134. The cylindrical portion 134 a assists with coupling thecannula assembly 116 to the first housing 110. The first housing 110 mayalso define a cannula guide portion 134 b, which may cooperate with aportion of the cannula assembly 116 to assist in coupling the cannulaassembly 116 to the first housing 110.

With reference back to FIG. 4, the coupling interface 136 is definedabout a perimeter of the first housing 110. The coupling interface 136defines a sidewall 136 a, and includes an interlock recess 138. Thesidewall 136 a extends about the perimeter of the first housing 110, andextends from the first surface 110 a generally so as to be substantiallyparallel to the center axis CA. The sidewall 136 a cooperates with thesecond housing 112 to substantially enclose the valve assembly 114, thecannula assembly 116, the continuous glucose monitor assembly 118 andthe control system 120. The interlock recess 138 is defined about aperimeter of the sidewall 136 a, and in one example, is a relief havinga triangular notch 138 a. The triangular notch 138 a interfaces with orinterlocks with a corresponding feature on the second housing 112 toassist in coupling the first housing 110 to the second housing 112 witha waterproof seal. It should be understood, however, that the interlockrecess 138 may not include the triangular notch 138 a, but rather maydefine an endwall that is substantially perpendicular to the center axisCA (FIG. 2) or that a notch associated with the interlock recess 138 mayhave a different shape.

The second housing 112 is coupled to the first housing 110. Withreference to FIG. 3, the second housing 112 includes a second receivingprojection 140, a third receiving projection 142, a controller receivingportion 144, a valve receiving portion 146 and a cannula receivingportion 148. The second receiving projection 140 cooperates with thereceiving projection 130 of the first housing 110 to receive thecontinuous glucose monitor assembly 118. In one example, with referenceto FIG. 4, the second receiving projection 140 is cylindrical, and has asecond diameter, which is different and, in this example, less than adiameter of the receiving projection 130. The second diameter is sizedto guide a portion of the continuous glucose monitor assembly 118 intothe anatomy. In addition, the reduced diameter of the second receivingprojection 140 enables the second receiving projection 140 to be atleast partially received within an opening 130 a defined by thereceiving projection 130. Thus, in this example, the second receivingprojection 140 is received within the receiving projection 130 of thefirst housing 110, and the continuous glucose monitor assembly 118 isreceived within both of the second receiving projection 140 and thereceiving projection 130. The second receiving projection 140 alsodefines a second bore 150. The second bore 150 is defined through thesecond housing 112. The second bore 150 enables a portion of thecontinuous glucose monitor assembly 118 to pass through the secondhousing 112 and into the anatomy when the wearable infusion port 102 iscoupled to a user. In this example, the diameter of the second bore 150is substantially the same as the diameter of the second receivingprojection 140.

The third receiving projection 142 receives a portion of the cannulaassembly 116. In this example, the third receiving projection 142 iscylindrical; however, the third receiving projection 142 may have anydesired shape. The third receiving projection 142 also defines a thirdbore 152. The third bore 152 is defined through the second housing 112.The third bore 152 enables a portion of the cannula assembly 116 to passthrough the second housing 112 and into the anatomy when the wearableinfusion port 102 is coupled to a user. In this example, the diameter ofthe third bore 152 is different than, and in this example, smaller thanthe diameter of the third receiving projection 142.

With reference to FIG. 3, the controller receiving portion 144 isdefined along a third surface 112 b of the second housing 112, which isopposite a second surface 112 a. In this example, the controllerreceiving portion 144 includes at least one or a pair of posts 144 a,which cooperates to retain the control system 120 within the secondhousing 112. The valve receiving portion 146 includes a first rib 154and a second rib 156. The first rib 154 and the second rib 156 may beintegrally formed with the second housing 112, or may be coupled to thesecond housing 112. The first rib 154 and the second rib 156 cooperateto define a circular region 158, which retains a portion of the valveassembly 114. The cannula receiving portion 148 is also defined by thefirst rib 154 and the second rib 156. In one example, the first rib 154and the second rib 156 also cooperate to define a substantiallyrectangular region 159, which retains a portion of the cannula assembly116.

The valve assembly 114 receives the fluid for infusion, which is insulinin this example, and is movable between an opened state and a closedstate. In the closed state, insulin is not dispensed and in the openedstate, the insulin is dispensed. With reference to FIG. 5, an explodedview of the valve assembly 114 is shown. In one example, the valveassembly 114 includes a rotor 160, a ratchet shim 162, a stator 164 andan actuator assembly 166.

The rotor 160 includes a rotor body 168 and a conduit sleeve 170. Therotor body 168 defines a disc 172, a conduit portion 174 and a shaft175. The rotor 160 may be composed of a suitable biocompatible material,such as a polymer-based material, metal or metal alloy, which is cast,molded, printed, stamped, etc. The rotor 160 may be integrally formed,or may compose separate components that are coupled together, viaultrasonic welding, for example. For example, the rotor body 168 and theconduit sleeve 170 may be discretely formed, and coupled together viaultrasonic welding. In one example, the rotor body 168 may include aplurality of teeth 168 b, which cooperate with a respective plurality ofmating teeth 170 c defined on the conduit sleeve 170 to couple theconduit sleeve 170 to the rotor body 168 with a press-fit. The disc 172is annular, and includes a first disc surface 176 and a second discsurface 178 opposite the first disc surface 176. A central bore 180 isdefined through the disc 172 and extends to the conduit portion 174. Thefirst disc surface 176 is substantially planar and smooth. Withreference to FIG. 5B, the second disc surface 178 includes a pluralityof angled notches 182, which are defined about a perimeter of thecentral bore 180. Each of the plurality of angled notches 182 includes aramp surface 182 a and a planar surface 182 b. The ramp surface 182 acooperates with the ratchet shim 162 to enable the ratchet shim 162 tomove in a direction, which in this example, is counterclockwise. Theplanar surface 182 b is orientated along an axis that is substantiallyparallel to a longitudinal axis L of the valve assembly 114. The planarsurface 182 b cooperates with the ratchet shim 162 to inhibit theratchet shim 162 from rotating clockwise. Thus, the planar surface 182 bforms a stop, which inhibits the rotation of the ratchet shim 162, andthus, the stator 164, as will be discussed further herein.

With reference to FIG. 4, the central bore 180 is in fluid communicationwith the first needle port 132 to receive the fluid or insulin from thefirst needle port 132. In one example, the central bore 180 includes aseptum 184, which serves to prevent the ingress and egress of fluidsinto/out of the rotor body 168. The septum 184 is pierceable by apiercing member of the syringe (not shown) to enable fluid flow from thesyringe into the rotor body 168. Thus, the septum 184 is downstream fromthe first needle port 132. The central bore 180 extends from the disc172 to the conduit portion 174 to provide the fluid, such as insulin, tothe conduit portion 174.

The conduit portion 174 of the rotor body 168 is in fluid communicationwith the central bore 180 and is defined downstream of the septum 184.The conduit portion 174 is defined between the disc 172 and the shaft175. In one example, the conduit portion 174 includes at least one or aplurality of rotor conduits 186, which are defined through the rotorbody 168. In one example, the conduit portion 174 includes about 9 rotorconduits 186, which are spaced apart about a perimeter or circumferenceof the conduit portion 174. In this example, the rotor conduits 186 arespaced about 40 degrees apart from each other about the circumference ofthe conduit portion 174. Each of the rotor conduits 186 extend from thecentral bore 180 to an exterior surface 168 a of the rotor body 168.Each of the rotor conduits 186 has an inlet 188 in fluid communicationwith the central bore 180 and an outlet 190 in fluid communication withthe conduit sleeve 170. The rotor conduits 186 are generally defined toextend along an axis that is substantially transverse or parallel to thelongitudinal axis L of the valve assembly 114, however, the rotorconduits 186 may have any desired orientation.

With reference back to FIG. 5, the shaft 175 is fixedly coupled to aportion of the actuator assembly 166. In one example, the shaft 175includes at least one or a plurality of teeth 192, which extendoutwardly from the shaft 175 at a terminal end 175 a of the shaft 175.In one example, the shaft 175 includes three teeth 192, which cooperatewith the portion of the actuator assembly 166 to enable the actuatorassembly 166 to drive the rotor 160 via the shaft 175, as will bediscussed herein.

The conduit sleeve 170 is non-rotatably coupled to the conduit portion174 of the rotor body 168. The conduit sleeve 170 is substantiallyannular, and defines at least one or a plurality of conduits 194 throughthe conduit sleeve 170. In one example, the conduit sleeve 170 includesabout 9 conduits 194, which are spaced apart about a perimeter orcircumference of the conduit sleeve 170. In this example, the rotorconduits 186 are spaced about 40 degrees apart from each other about thecircumference of the conduit sleeve 170. With reference to FIG. 4, eachof the conduits 194 extend from an inner surface or diameter 170 a ofthe conduit sleeve 170 to an exterior surface or diameter 170 b of theconduit sleeve 170. Each of the conduits 194 has a conduit inlet 196,which is in fluid communication with the outlet 190 of a respective oneof the rotor conduits 186; and a conduit outlet 198, which is in fluidcommunication with an outlet 200 of the stator 164 based on a state ofthe valve assembly 114. The conduits 194 are generally defined to extendalong an axis that is substantially transverse or parallel to thelongitudinal axis L of the valve assembly 114, however, the conduits 194may have any desired orientation.

With reference back to FIG. 5, the ratchet shim 162 is coupled betweenthe rotor 160 and the stator 164. In one example, the ratchet shim 162is non-rotatably coupled to the stator 164, and inhibits a clockwiserotation of the rotor 160. It should be noted that while the rotation ofthe rotor 160 is described herein as being counterclockwise, the valveassembly 114 may be configured if desired to rotate in a clockwisedirection. Generally, the rotor 160 rotates in a counterclockwisedirection relative to the ratchet shim 162, and the ratchet shim 162cooperates with the disc 172 of the rotor 160 to inhibit clockwisemotion of the rotor 160. The ratchet shim 162 may be composed of asuitable biocompatible material, such as a polymer-based material, metalor metal alloy, which is cast, molded, printed, stamped, etc. In oneexample, the ratchet shim 162 is annular and includes a shim bore 202,at least one or a plurality of mounting bores 204 and at least one or aplurality of anti-rotation tabs 206.

The shim bore 202 is defined through the ratchet shim 162 along thelongitudinal axis L of the valve assembly 114, and is sized to enablethe ratchet shim 162 to be positioned about the conduit sleeve 170 ofthe rotor 160. The mounting bores 204 are defined through the ratchetshim 162 and are spaced apart about a perimeter of the shim bore 202.The mounting bores 204 cooperate with or receive a respective one ofcorresponding projections 208 that extend outwardly from the stator 164to non-rotatably couple the ratchet shim 162 to the stator 164. Itshould be noted that other engaging features may be employed tonon-rotatably couple the ratchet shim 162 to the stator 164. Theanti-rotation tabs 206 are defined at a perimeter or outer circumferenceof the ratchet shim 162. In one example, the ratchet shim 162 includesthree anti-rotation tabs 206, but the ratchet shim 162 may include anynumber of anti-rotation tabs 206. Each of the anti-rotation tabs 206 iscantilevered relative to the ratchet shim 162, and is inclined relativeto a surface 162 a of the ratchet shim 162. In this regard, each of theanti-rotation tabs 206 is inclined at a positive angle or upward toengage with the plurality of angled notches 182 of the disc 172. In oneexample, the anti-rotation tabs 206 are inclined by an angle α, which isabout 15 to about 180 degrees. The angle α is sized to enable theanti-rotation tabs 206 to move along the ramp surface 184 a (FIG. 5B) ofthe disc 172 as the rotor rotates in the counterclockwise direction, butto contact the planar surface 184 b (FIG. 5B) in the rotation of therotor 160 in the clockwise direction. The contact between theanti-rotation tabs 206 and the planar surfaces 184 b inhibits therotation of the rotor 160 in the clockwise direction.

The stator 164 is coupled to the ratchet shim 162, and to the rotor 160.The stator 164 is coupled to the rotor 160 to enable the rotor to moverelative to the stator 164. The stator 164 may be composed of a suitablebiocompatible material, such as a polymer-based material, metal or metalalloy, which is cast, molded, printed, stamped, etc. The stator 164includes a body 210 that defines a ratchet flange 212, an actuator shaftreceiving portion 214, an actuator receiving portion 216, a conduitreceiving portion 218 and the outlet 200. The stator 164 also defines acentral stator bore 219. The central stator bore 219 is defined alongthe longitudinal axis L of the valve assembly 114, and is sized toreceive the rotor 160 within the stator 164. Generally, the centralstator bore 219 is sized and shaped to receive the conduit sleeve 170,the conduit portion 174 and the shaft 175 of the rotor 160, while thedisc 172 is positioned external to the stator 164 for engagement withthe ratchet shim 162.

The ratchet flange 212 is defined on the body 210 opposite the actuatorreceiving portion 216. The ratchet flange 212 is circular, and includesthe projections 208. The ratchet flange 212 may include a lip 221, whichis defined about a perimeter of the ratchet flange 212 to further assistin retaining the ratchet shim 162 within the ratchet flange 212. Theactuator shaft receiving portion 214 receives a portion of the actuatorassembly 166. In one example, the actuator shaft receiving portion 214is substantially cylindrical, with open opposed ends 214 a, 214 b. Theactuator shaft receiving portion 214 extends along an axis, which issubstantially transverse or perpendicular to the longitudinal axis L ofthe valve assembly 114. The actuator shaft receiving portion 214 mayalso include a flange 215. With reference to FIGS. 5C and 5D, the flange215 may extend about a perimeter of the actuator shaft receiving portion214 proximate the end 214 a, and may include a bore 215 a. The bore 215a may receive a mechanical fastener, such as a screw, pin, post, etc. tocouple the actuator shaft receiving portion 214 to the control system120. Generally, the flange 215 is composed of a conductive material, andthe control system 120 is configured to supply a current to the flange215. The current received by the flange 215 is transferred to theactuator shaft 232 to move the valve assembly 114 from the closed stateto the opened state. In one example, the flange 215 includes a couplingportion 215 b, which receives an actuator wire 234 of the actuator shaft232. The coupling portion 215 b is electrically and physically coupledto the actuator wire 234 to transfer the current received from thecontrol system 120 to the actuator wire 234 via the flange 215. Inaddition, the actuator shaft receiving portion 214 may also include asecond flange 217. The second flange 217 may extend about a perimeter ofthe actuator shaft receiving portion 214 proximate the end 214 b and isphysically and electrically coupled to the actuator wire 234. Generally,the second flange 217 is composed of a conductive material, and thecontrol system 120 is configured to receive a current from the secondflange 217 such that current flows through the actuator wire 234 fromthe flange 215 to the second flange 217. The current received by thesecond flange 217 is returned to the control system 120. In one example,the second flange 217 includes a second coupling portion 217 b, whichreceives a portion of the actuator wire 234. The second coupling portion217 b is electrically and physically coupled to the actuator wire 234 totransfer the current received through the actuator wire 234 to thecontrol system 120.

With reference to FIG. 4, the actuator shaft receiving portion 214 is incommunication with the actuator receiving portion 216. The actuatorreceiving portion 216 is substantially cylindrical, and is sized toreceive a portion of the cannula assembly 116. The actuator receivingportion 216 may also define a guide 222 on an external surface 216 a.The guide 222 cooperates with a portion of the cannula assembly 116 toensure the proper assembly of the valve assembly 114 to the cannulaassembly 116.

With reference back to FIG. 5, the conduit receiving portion 218 isdefined within the body 210 between the ratchet flange 212 and theactuator receiving portion 216. The conduit receiving portion 218 issized to surround the conduit sleeve 170 of the rotor 160 when the rotor160 is coupled to the stator 164. With reference to FIG. 4, the conduitreceiving portion 218 also includes an outlet conduit 224. The outletconduit 224 is fluidly coupled to one of the conduits 194 of the conduitsleeve 170 based on the state of the valve assembly 114, and is fluidlycoupled to the outlet 200. The outlet conduit 224 includes an outletconduit inlet 226 that is fluidly coupled to one of the conduits 194based on the state of the valve assembly 114; and an outlet conduitoutlet 228 that is fluidly coupled to the outlet 200. The outlet conduit224 is generally defined to extend along an axis that is substantiallytransverse or parallel to the longitudinal axis L of the valve assembly114, however, the outlet conduit 224 may have any desired orientation.The outlet 200 is fluidly coupled to the cannula assembly 116. Thus, theoutlet conduit 224 directs the fluid or insulin received from theconduit sleeve 170 of the rotor 160 to the cannula assembly 116.

The actuator assembly 166 is responsive to one or more control signalsfrom the control system 120 to move the rotor 160. As will be discussed,the rotation of the rotor 160 moves the valve assembly 114 between theopened state and the closed state. The actuator assembly 166 includes abiasing member or spring 230, an actuator shaft 232, an actuator wire234, an actuator pinion 236, an actuator shim 238 and an end plate 240.

The spring 230 is a coil spring. The spring 230 is composed of a springsteel, and may be extruded and wound to form the spring 230. The spring230 is coupled to an exterior surface 232 a of the actuator shaft 232,and applies a spring force Fs against a collar 242 of the actuator shaft232 to bias the actuator shaft 232 into a first position and sitsagainst a spring seat 230 a defined in the actuator shaft receivingportion 214 (FIG. 5D). When the actuator shaft 232 is in the firstposition, the valve assembly 114 is in the closed state. As will bediscussed, the actuator shaft 232 is movable to a second position, inwhich the valve assembly 114 is in the opened state.

The actuator shaft 232 is cylindrical, and is received within theactuator shaft receiving portion 214 of the stator 164. The actuatorshaft 232 may be composed of a suitable biocompatible material, such asa polymer-based material, metal or metal alloy, which is cast, molded,printed, stamped, etc. The actuator shaft 232 includes the collar 242,at least one or a plurality of shaft teeth 244, a wire receiving channel246 and opposed ends 248, 250. The collar 242 is defined about theexterior surface 232 a of the actuator shaft 232. The collar 242 isdefined to extend about only a portion of the exterior surface 232 a,such that the opposed ends 248, 250 of the actuator shaft 232 have adiameter, which is different, and less than, a diameter of the collar242. The collar 242 includes a recess 252 defined along one side of theactuator shaft 232. The shaft teeth 244 are defined within the collar242. The shaft teeth 244 form a rack, which engages with the actuatorpinion 236. With reference to FIG. 5E, the actuator shaft 232 define aslot 245 opposite the shaft teeth 244 to assist in the manufacturing ofthe shaft teeth 244.

With reference back to FIG. 5, the wire receiving channel 246 is definedby an inner circumference of the actuator shaft 232. The wire receivingchannel 246 extends between the opposed ends 248, 250. The wirereceiving channel 246 is sized to receive the actuator wire 234. Theopposed ends 248, 250 cooperate with the actuator wire 234. In oneexample, the opposed end 248 is circumferentially open to enable theactuator wire 234 to extend through the opposed end 248. The opposed end250 includes a flange 254, which circumferentially closes the opposedend 250. The flange 254 is recessed within the opposed end 250, andprovides a stop for a portion of the actuator wire 234. The flange 254also defines a throughbore 254 a, which enables a portion of theactuator wire 234 to pass through the flange 254.

The actuator wire 234 extends through the actuator shaft 232. Theactuator wire 234 includes a first post 256, a second post 258 oppositethe first post 256 and a wire 260. The first post 256 and the secondpost 258 are generally cylindrical, and have a diameter that is greaterthan a diameter of the wire 260. The first post 256 and the second post258 may be composed of a suitable conductive material, such as a metalor metal alloy, which is cast, molded, printed, stamped, etc. The firstpost 256 and the second post 258 may be coupled to the wire 260 viapress-fit, ultrasonic welding, etc. With reference to FIG. 5D, the firstpost 256 is coupled to the end 214 a of the actuator shaft receivingportion 214 of the stator 164. The second post 258 extends beyond theactuator shaft 232 and is physically and electrically coupled to thesecond flange 217 and is movable to contact the flange 254 (FIG. 5). Thefirst post 256 is physically and electrically coupled to the flange 215to receive the current from the control system 120, which is conductedthrough the wire 260 to the second flange 217. The second post 258contacts the flange 254 during a second, contracted state of the wire260 to translate the actuator shaft 232, as will be discussed.

The wire 260 is a shape memory wire, and in one example, is a nitinolwire. Opposed ends of the wire 260 are coupled to a respective one ofthe first post 256 and the second post 258. In this example, the controlsystem 120 supplies the current to the flange 215, which is received bythe wire 260 via the first post 256 and is conducted by the wire 260 tothe second flange 217, which conducts the current back to the controlsystem 120. The current conducted by the wire 260 causes the wire toincrease in temperature. The increase in temperature of the wire 260causes the wire 260 to move from a first, extended state to a second,contracted state. In the first, extended state, the wire 260 iselongated within the wire receiving channel 246 as shown in FIG. 5, andthe force Fs of the spring 230 maintains the actuator shaft 232 in thefirst position. In the second, contracted state, the wire 260 contracts,which pulls the second post 258 into contact with the flange 254. Thecontinued contraction of the wire 260 along with the contact between thesecond post 258 and the flange 254 causes the actuator shaft 232 totranslate within the actuator shaft receiving portion 214, which inturn, causes the shaft teeth 244 to rotate the actuator pinion 236. Therotation of the actuator pinion 236 drives the rotor 160 to dispense thefluid or insulin, as will be discussed.

The actuator pinion 236 is annular; and has a first side 262 opposite asecond side 264 and a central pinion bore 266. The actuator pinion 236may be composed of a suitable biocompatible material, such as apolymer-based material, metal or metal alloy, which is cast, molded,printed, stamped, etc. The first side 262 defines at least one or aplurality of pinion teeth 268. The pinion teeth 268 are defined about aperimeter or circumference of the central pinion bore 266. The pinionteeth 268 matingly engage with the shaft teeth 244 such that a linear ortranslational movement of the actuator shaft 232 causes a rotation ofthe actuator pinion 236. The second side 264 of the actuator pinion 236receives and retains the actuator shim 238. The second side 264 includesat least one or a plurality of projections 270 (FIG. 6). The second side264 may also include a lip 272 (FIG. 6), which is defined about aperimeter of the second side 264 to further assist in retaining theactuator shim 238 within the second side 264 of the actuator pinion 236.The central pinion bore 266 is coupled to the shaft 175 of the rotor160. In one example, the shaft 175 is coupled to the central pinion bore266 via ultrasonic welding, however, other techniques may be employed tocouple the actuator pinion 236 to the shaft 175. With the rotor 160coupled to the actuator pinion 236, the rotation of the actuator pinion236 via the actuator shaft 232 rotates the rotor 160 in thecounterclockwise direction.

With reference to FIG. 5, the actuator shim 238 is coupled between theactuator pinion 236 and the end plate 240. In one example, the actuatorshim 238 is non-rotatably coupled to the actuator pinion 236, andinhibits a clockwise rotation of the rotor 160. It should be noted thatwhile the rotation of the rotor 160 is described herein as beingcounterclockwise, the rotor 160 of the valve assembly 114 may beconfigured if desired to rotate in a clockwise direction. Generally, theactuator pinion 236 rotates relative to the actuator shim 238, and theactuator shim 238 cooperates with the end plate 240 to inhibit clockwisemotion of the rotor 160. The actuator shim 238 may be composed of asuitable biocompatible material, such as a polymer-based material, metalor metal alloy, which is cast, molded, printed, stamped, etc. In oneexample, the actuator shim 238 is annular and includes an actuator shimbore 274, at least one or a plurality of mounting bores 276 and at leastone or a plurality of anti-rotation tabs 278.

The actuator shim bore 274 is defined through the actuator shim 238along the longitudinal axis L of the valve assembly 114, and is sized toenable the actuator shim 238 to be positioned about the shaft 175 of therotor 160. The mounting bores 276 are defined through the actuator shim238 and are spaced apart about a perimeter of the actuator shim bore274. The mounting bores 276 cooperate with or receive a respective oneof the projections 270 (FIG. 6) that extend outwardly from the secondside 264 of the actuator pinion 236 to non-rotatably couple the actuatorshim 238 to the actuator pinion 236. This ensures that the actuator shim238 rotates with the actuator pinion 236. It should be noted that otherengaging features may be employed to non-rotatably couple the actuatorshim 238 to the actuator pinion 236. The anti-rotation tabs 278 aredefined at a perimeter or outer circumference of the actuator shim 238.In one example, the actuator shim 238 includes three anti-rotation tabs278, but the actuator shim 238 may include any number of anti-rotationtabs 278. Each of the anti-rotation tabs 278 is cantilevered relative tothe actuator shim 238, and is inclined relative to a surface 238 a ofthe actuator shim 238. In this regard, each of the anti-rotation tabs278 is inclined at a negative angle or downward to engage with aplurality of angled notches 280 of the end plate 240. In one example,the anti-rotation tabs 278 are inclined by an angle α₁, which is about15 to about 180 degrees. The angle α₁ is sized to enable theanti-rotation tabs 278 to move along a ramp surface 280 a of the endplate 240 as the end plate 240 rotates in the counterclockwisedirection, but to contact a planar surface 280 b in the rotation of theend plate 240 in the clockwise direction. The contact between theanti-rotation tabs 278 and the planar surfaces 280 b of the end plate240 drives the rotor 160 counterclockwise and inhibits the rotation ofthe rotor 160 in the clockwise direction.

The end plate 240 includes a first plate side 282 opposite a secondplate side 284 and a central plate bore 286. The end plate 240 may becomposed of a suitable biocompatible material, such as a polymer-basedmaterial, metal or metal alloy, which is cast, molded, printed, stamped,etc. The first plate side 282 includes the plurality of angled notches280, which are defined about a perimeter of the central plate bore 286.Each of the plurality of angled notches 280 includes the ramp surface280 a and the planar surface 280 b. The ramp surface 280 a cooperateswith the actuator shim 238 to enable the end plate 240 to move in adirection, which in this example, is counterclockwise. The planarsurface 280 b is orientated along an axis that is substantially parallelto the longitudinal axis L of the valve assembly 114. The planar surface280 b cooperates with the actuator shim 238 to inhibit the end plate 240from rotating clockwise. Thus, the planar surface 280 b forms a stop,which inhibits the rotation of the end plate 240, and thus, the rotor160. The second plate side 284 is substantially planar or smooth (FIG.4). The second plate side 284 is coupled to the third surface 112 b ofthe second housing 112. The central plate bore 286 is defined throughthe end plate 240 along the longitudinal axis L. The central plate bore286 includes a plurality of slots 286 a, which extend radially outwardfrom the central plate bore 286. Each of the slots 286 a is sized andshaped to receive a corresponding one of the teeth 192 of the shaft 175.The engagement of the teeth 192 with the respective slots 286 a rigidlycouples the rotor 160 to the end plate 240.

With reference to FIG. 7, the cannula assembly 116 is fluidly coupled tothe outlet 200 of the valve assembly 114 to receive the fluid orinsulin. The cannula assembly 116 receives the fluid or insulin from thevalve assembly 114 and meters the delivery of the fluid to the user. Inone example, the cannula assembly 116 includes a needle septum 290, acannula plug 292, a cannula 294, a cannula sealing member 296, a flowsensor 298 and a flow sensor housing 300. With brief reference to FIG.4, the needle septum 290 is positioned between the second needle port134 and the cannula plug 292. Thus, the needle septum 290 is downstreamfrom the second needle port 134. The needle septum 290 serves to preventthe ingress and egress of fluids out of the cannula plug 292. The needleseptum 290 is pierceable by a piercing member of the insertion device(not shown) to couple the cannula 294 to the user.

The cannula plug 292 is positioned between the needle septum 290 and thecannula 294. The cannula plug 292 couples the cannula 294 to the flowsensor housing 300. The cannula plug 292 may be composed of a suitablebiocompatible material, such as a polymer-based material, metal or metalalloy, which is cast, molded, printed, stamped, etc. In one example, thecannula plug 292 includes a first plug portion 302, a second plugportion 304 and a sealing band 306. The first plug portion 302 has afirst end 308 opposite a second end 310, and has a sidewall 312 thatinterconnects the first end 308 with the second end 310. The first plugportion 302 is substantially cylindrical and hollow. The first end 308defines a first end bore 308 a, which is sized to receive a needleassociated with the insertion device for coupling the cannula 294 to theuser. The second end 310 is coupled to the second plug portion 304. Thesecond end 310 is also received within the flow sensor housing 300 suchthat the second end 310 compresses the cannula sealing member 296 toform a seal between the cannula plug 292 and the flow sensor housing300. With reference to FIG. 4, the sidewall 312 defines a conduit 314and a groove 315. The conduit 314 is fluidly coupled to the outlet 200of the valve assembly 114 to receive the fluid or insulin, and isfluidly coupled to the cannula 294 to provide the cannula 294 with thefluid or insulin. In this example, the conduit 314 includes an inlet 314a fluidly coupled to the sealing band 306, and an outlet 314 b fluidlycoupled to the hollow interior of the first plug portion 302.

With reference to FIG. 7, the second plug portion 304 is coupled to orintegrally formed with the first plug portion 302. The second plugportion 304 includes a cylindrical section 316 and a tapered section318. The cylindrical section 316 is hollow, and is fluidly coupled tothe first plug portion 302. The tapered section 318 is fluidly coupledto the cylindrical section 316, and is hollow. The tapered section 318is circumferentially open to enable the fluid received by the inlet 314a of the first plug portion 302 to flow into the cannula 294 (FIG. 4).It should be noted that the shape of the second plug portion 304 withthe cylindrical section 316 and the tapered section 318 is merelyexemplary, as the second plug portion 304 may have any desired shape tomate with the cannula 294. In this regard, generally, the second plugportion 304 is received within a proximal end 320 of the cannula 294 tocouple the cannula 294 to the cannula plug 292. In one example, thesecond plug portion 304 forms a press-fit with the proximal end 320,however, other techniques may be employed.

The sealing band 306 is coupled about the first plug portion 302. Thesealing band 306 may be integrally or discretely formed with the firstplug portion 302. In one example, the sealing band 306 is coupled to thefirst plug portion 302 to form a press-fit with the flow sensor housing300 (FIG. 4). Generally, the sealing band 306 has a diameter that isdifferent than, and in this example, greater than a diameter of thefirst plug portion 302 such that the sealing band 306 extends outwardlyfrom the first plug portion 302 to form an interference fit or press-fitwith the flow sensor housing 300. With brief reference to FIG. 4, thesealing band 306 includes a band conduit 322, which is in fluidcommunication with the outlet 200 and the cannula 294. In this regard,the band conduit 322 includes a band inlet 322 a fluidly coupled to theflow sensor housing 300; and a band outlet 322 b fluidly coupled to theconduit 314.

The cannula 294 is coupled to the cannula plug 292, and is configured tobe inserted into the subcutaneous tissue of a user via the insertiondevice (not shown). The cannula 294 is a hollow tubular structure, andincludes the proximal end 320 and a distal end 324. With reference backto FIG. 7, the proximal end 320 is configured and shaped to cooperatewith the second plug portion 304 to couple the cannula 294 to thecannula plug 292. In this example, the proximal end 320 includes acylindrical section 320 a and a tapered section 320 b. The cylindricalsection 320 a is sized to surround the cylindrical section 316 of thecannula plug 292, and the tapered section 320 b is sized to surround thetapered section 318 of the cannula plug 292. The proximal end 320 alsodefines a cannula inlet 326 (FIG. 4). The cannula inlet 326 is fluidlycoupled to the cannula plug 292 to receive the fluid or insulin from theflow sensor housing 300, and thus, the outlet 200 of the valve assembly114, as will be discussed. The distal end 324 may be blunt or pointed,and is configured to be inserted into the subcutaneous tissue of theuser when the wearable infusion port 102 is coupled to the user.

The cannula sealing member 296 is compressed by the cannula plug 292 tocreate a seal between the cannula 294 and the flow sensor housing 300.In one example, the cannula sealing member 296 is an elastomeric O-ring,however, other sealing mechanisms may be employed. The cannula sealingmember 296 is sized to be positioned within the flow sensor housing 300and between the second end 310 of the first plug portion 302 and thethird receiving projection 142 of the second housing 112 (FIG. 4).

The flow sensor 298 is received within the flow sensor housing 300. Theflow sensor 298 is in fluid communication with the cannula plug 292 andthe outlet 200. The flow sensor 298 observes an amount of fluid thatpasses through the flow sensor housing 300 from the outlet 200, andgenerates one or more signals based on the observation. The flow sensor298 is in communication with the control system 120 to provide thecontrol system 120 with the sensor signals. In one example, the flowsensor 298 observes a volume of the insulin that passes through the flowsensor housing 300 to the cannula plug 292, through the cannula plug 292to the cannula 294 and into the user. Thus, the flow sensor 298 observesa volume of the fluid or insulin that is dispensed by the valve assembly114. As will be discussed, based on the signals received from the flowsensor 298, the control system 120 may output one or more controlsignals to the valve assembly 114 to move the valve assembly 114 fromthe opened state to the closed state.

In one example, the flow sensor 298 is a thermal mass flow sensor, whichdetects flow rates from about 1.0 to about 40.0 milliliters per minute(mL/min). In this example, the flow sensor 298 includes a heat source orheater 328 and a pair of temperature sensors 329 a, 329 b on either sideof the heater. The heater 328 and the temperature sensors 329 a, 329 bare coupled to or in communication with a flow conduit 331 definedwithin the flow sensor 298 (FIG. 4). The heater 328 heats the fluid orinsulin as the fluid passes through the flow sensor 298. One of thetemperature sensors observe a first temperature of the fluid (prior toheating) and the other one of the temperature sensors observes a secondtemperature of the fluid (after heating). The signals from thetemperature sensors 329 a, 329 b are communicated to the control system120, and the control system 120 determines the volume of the fluiddelivered based on a difference between the two temperature signals. Thesignals from the temperature sensors may be filtered, if desired, toaccount for turbulence. It should be noted, alternatively, the flowsensor 298 may also include a monitor module, which determines thevolume based on the temperature signals, and transmits the determinedvolume to the control system 120.

In this example, with reference to FIG. 4, the flow sensor 298 includesa sensor inlet 330 in fluid communication with the outlet 200 and asensor outlet 332 in fluid communication with the cannula plug 292. Apair of sealing members 334 a, 334 b may be coupled about a respectiveone of the sensor inlet 330 and the sensor outlet 332 to provide a sealbetween the flow sensor 298 and the flow sensor housing 300. In oneexample, the sealing members 334 a, 334 b are elastomeric O-rings,however, other sealing mechanisms may be employed. In this example, theflow sensor 298 includes a separate housing 298 a, which includes thesensor inlet 330 and the sensor outlet 332, and also contains orencloses the temperature sensors 329 a, 329 a, the heater 328 and theflow conduit 331. It should be noted that the flow sensor 298 need notinclude a separate housing 298 a, but may be defined within the flowsensor housing 300, if desired. The flow sensor 298 is received withinthe flow sensor housing 300, which defines a housing inlet conduit 336and a housing outlet conduit 338. The housing inlet conduit 336 isfluidly coupled to the outlet 200 and the sensor inlet 330; and thehousing outlet conduit 338 is fluidly coupled to the sensor outlet 332and the band conduit 322 to provide the fluid or insulin to the cannula294.

With reference back to FIG. 7, the flow sensor housing 300 defines acannula receiving portion 340, a sensor receiving portion 342 and aconnecting portion 344. The flow sensor housing 300 may be composed of asuitable biocompatible material, such as a polymer-based material, metalor metal alloy, which is cast, molded, printed, stamped, etc. With briefreference to FIG. 4, the cannula receiving portion 340 is cylindrical,and is sized to receive the cannula plug 292 and the cannula 294. Thecannula receiving portion 340 is positioned over the third receivingprojection 142 of the second housing 112 (FIG. 4). The cannula receivingportion 340 is fluidly coupled to the sensor receiving portion 342 viathe housing outlet conduit 338, which is defined in the cannulareceiving portion 340. With reference back to FIG. 7, the sensorreceiving portion 342 is substantially rectangular, however, the sensorreceiving portion 342 may have any desired shape to receive the flowsensor 298. The sensor receiving portion 342 also defines channels 342 a(FIG. 4), which receive a portion of the sealing members 334 a, 334 b tocreate the seal between the flow sensor 298 and the flow sensor housing300. The connecting portion 344 fluidly couples the valve assembly 114to the cannula assembly 116. In one example, the connecting portion 344is cylindrical, and includes a sealing member 346. In this example, thesealing member 346 is an elastomeric O-ring, however, other sealingmechanisms may be employed. The sealing member 346 is received within aninlet 348 of the flow sensor housing 300 and forms a seal about theoutlet 200 of the stator 164 and the flow sensor housing 300, as shownin FIG. 4. The connecting portion 344 also defines the housing inletconduit 336, which fluidly couples the outlet 200 to the sensor inlet330.

The continuous glucose monitor assembly 118 is positionable within thereceiving projection 130 of the first housing 110, and is also receivedwithin the second receiving projection 140 of the second housing 112. Itshould be noted that the continuous glucose monitor assembly 118 may beoptional, and that the wearable infusion port 102 need not include thecontinuous glucose monitor assembly 118, if desired. If the continuousglucose monitor assembly 118 is not employed with the wearable infusionport 102, the receiving projection 130 of the first housing 110 mayreceive a plug or other structure to enclose the receiving projection130, if desired. With reference to FIG. 8, the continuous glucosemonitor assembly 118 includes a sensor sealing member 350, a firstsensor housing 352, a sensor septum 354, a glucose sensor 356, a secondsensor housing 358 and a second sensor sealing member 360. The sensorsealing member 350 creates a seal between the first sensor housing 352and the first housing 110 (FIG. 4). In one example, the sensor sealingmember 350 is an elastomeric O-ring, however, other sealing mechanismsmay be employed. The sensor sealing member 350 is received within a sealgroove 362 defined in the first sensor housing 352, and extends about aperimeter of the first sensor housing 352.

The first sensor housing 352 is coupled to the second sensor housing358. The first sensor housing 352 and the second sensor housing 358 areeach composed of a suitable biocompatible material, such as apolymer-based material, metal or metal alloy, which is cast, molded,printed, stamped, etc. The first sensor housing 352 includes a firstbase 364 and a pair of legs 366. The first base 364 includes a topsurface 365 and an opposite bottom surface 368. The top surface 365defines a bore 365 a, which enables the receipt of a needle from aninserter (not shown) to couple the glucose sensor 356 to the user. Theseal groove 362 is defined about the perimeter or circumference of thefirst base 364 between the top surface 365 and the bottom surface 368.With reference to FIG. 4, the bottom surface 368 includes a groove 368a, which assists in coupling the first sensor housing 352 to the secondsensor housing 358.

The legs 366 couple the continuous glucose monitor assembly 118 to thefirst housing 110. In one example, each of the legs 366 are cantileveredrelative to the first base 364 such that the legs 366 may flex relativeto the first base 364. Each of the legs 366 includes a lip 367 at adistalmost end 366 a. The lip 367 cooperates with the receivingprojection 130 of the first housing 110 to couple or retain thecontinuous glucose monitor assembly 118 within the first housing 110, asshown in FIG. 4. In one example, the lips 367 cooperate with an endwall130 b of the receiving projection 130 to form a snap-fit, which securesthe continuous glucose monitor assembly 118 within the first housing110. Generally, upon insertion of the continuous glucose monitorassembly 118, the legs 366 deflect slightly inward toward the glucosesensor 356. Once the continuous glucose monitor assembly 118 is fullyinserted, the legs 366 extend past the endwall 130 b, which enables thelegs 366 to deflect outward and the lips 367 to engage with the endwall130 b.

With reference back to FIG. 8, the sensor septum 354 is coupled betweenthe bottom surface 368 and the glucose sensor 356. The sensor septum 354serves to prevent the ingress and egress of fluids into/out of theglucose sensor 356. The sensor septum 354 is pierceable by a piercingmember of the insertion device to enable the insertion device to couplethe glucose sensor 356 to the user. The sensor septum 354 also serves tocompress the glucose sensor 356 to ensure that electrical contact ismaintained between the glucose sensor 356 and the second sensor housing358.

The glucose sensor 356 employed with the sensor inserter is a continuousglucose sensor of the type used by diabetic users. For the sake ofbrevity, conventional aspects and technology related to glucose sensorsand glucose sensor fabrication may not be described in detail here. Inthis regard, known and/or conventional aspects of glucose sensors andtheir manufacturing may be of the type described in, but not limited to:U.S. Pat. Nos. 6,892,085, 7,468,033 and 9,295,786; and United Statespatent application number 2009/0299301 (which are each incorporated byreference herein). Generally, the glucose sensor 356 is anelectrochemical sensor that includes the glucose oxidase enzyme, as iswell understood by those familiar with glucose sensor technology. Theglucose oxidase enzyme enables the glucose sensor 356 to monitor bloodglucose levels in a diabetic patient or user by effecting a reaction ofglucose and oxygen. Again, although certain embodiments pertain toglucose sensors, the technology described here can be adapted for usewith any one of the wide variety of sensors known in the art and is notlimited to glucose sensors. Generally, the glucose sensor 356 includes adistal end 356 a, which is positionable in subcutaneous tissue of theuser by an insertion needle of the insertion device to measure theglucose oxidase enzyme. A proximal end 356 b of the glucose sensor 356is physically and electrically coupled to the second sensor housing 358.The signals from the glucose sensor 356 are transmitted to the controlsystem 120 via the second sensor housing 358.

The second sensor housing 358 includes a second sensor receiving portion370 and an outer sleeve 372. The second sensor receiving portion 370 iscylindrical in shape; and has a first end 374 and an opposite second end376. The first end 374 is sized to receive and surround the sensorseptum 354. The first end 374 also receives the proximal end 356 b ofthe glucose sensor 356. Generally, the proximal end 356 b of the glucosesensor 356 is coupled between the sensor septum 354 and an inner wall374 a of the first end 374 (FIG. 4). The first end 374 has a diameter,which is different, and in this example, less than a diameter of thesecond end 376. The second end 376 receives a portion of the glucosesensor 356 and guides the glucose sensor 356 during the insertion of theglucose sensor 356 into the anatomy. The second end 376 defines asealing groove 378 about a perimeter or circumference of the sealinggroove 378. The sealing groove 378 receives the second sensor sealingmember 360.

The outer sleeve 372 surrounds a portion of the perimeter orcircumference of the second sensor receiving portion 370. Generally, theouter sleeve 372 is disposed about the circumference of the secondsensor receiving portion 370 so as to be disposed about a portion of theperimeter of the second receiving projection 140 of the second housing112 when the continuous glucose monitor assembly 118 is coupled to thesecond housing 112 (FIG. 4). In one example, the outer sleeve 372 issubstantially C-shaped, and includes one or more electrical contacts380. The electrical contacts 380 electrically couple the glucose sensor356 to the control system 120. The electrical contacts 380 may becoupled to the outer sleeve 372 via insert molding, adhesives,ultrasonic welding, etc. The outer sleeve 372 creates a waterproofinterface to the second housing 112 with the second sensor sealingmember 360.

The second sensor sealing member 360 creates a seal between the outersleeve 372 and the second housing 112 (FIG. 4). In one example, thesecond sensor sealing member 360 is an elastomeric O-ring, however,other sealing mechanisms may be employed. The second sensor sealingmember 360 is received within the sealing groove 378 defined in thefirst sensor housing 352, and extends about a perimeter of the firstsensor housing 352.

With reference to FIG. 4, the control system 120 includes a power supply390, a communication device 392 and a controller 394. In one example,the power supply 390, the communication device 392 and the controller394 are physically and electrically coupled together via a circuit board396. The power supply 390 supplies power to the controller 394, which inturn supplies power to the wire 260, the flow sensor 298 and thecommunication device 392. In one example, the power supply 390 comprisesa pair of coin cell batteries 390 a, 390 b. It should be noted, however,that any suitable power supply 390 may be employed with the controlsystem 120, including, but not limited to, rechargeable batteries, solarcells, etc.

The communication device 392 enables wireless communication between thewearable infusion port 102 and a remote device, such as a portableelectronic device associated with the user, including, but not limitedto a cell phone, tablet, personal computer, smart watch, smart glasses,infusion pump, etc. The communication device 392 is in communicationwith the portable electronic device via any suitable communicationprotocol supported by the portable electronic device. In an exemplaryembodiment, the communication device 392 is a wireless communicationsystem configured to communicate via a wireless local area network(WLAN) using IEEE 802.11 standards, Bluetooth® or by using cellular datacommunication. Thus, the communication device 392 includes, but is notlimited to, a Bluetooth® transceiver, a radio transceiver, a cellulartransceiver, a 2G/3G/4G LTE transceiver and/or a Wi-Fi transceiver. Thecommunication device 392 can also comprise a one-way transmitter. Thecommunication device 392 may also be configured to encode data orgenerate encoded data. The encoded data generated by the communicationdevice 392 may be encrypted. Thus, the communication device 392 enablesthe controller 394 of the wearable infusion port 102 to communicatedata, such as the volume of fluid dispensed by the valve assembly 114(as observed by the flow sensor 298), a blood glucose level of the user(as observed by the glucose sensor 356), etc. The communication device392 also enables the controller 394 to receive data, such as a volume offluid to be dispensed to the user, from the remote device.

The controller 394 includes at least one processor 398 and a computerreadable storage device or media 400. The processor 398 can be anycustom made or commercially available processor, a central processingunit (CPU), a graphics processing unit (GPU), an auxiliary processoramong several processors associated with the controller 394, asemiconductor based microprocessor (in the form of a microchip or chipset), a macroprocessor, any combination thereof, or generally any devicefor executing instructions. The computer readable storage device ormedia 400 may include volatile and nonvolatile storage in read-onlymemory (ROM), random-access memory (RAM), and keep-alive memory (KAM),for example. KAM is a persistent or non-volatile memory that may be usedto store various operating variables while the processor 398 is powereddown. The computer-readable storage device or media 400 may beimplemented using any of a number of known memory devices such as PROMs(programmable read-only memory), EPROMs (electrically PROM), EEPROMs(electrically erasable PROM), flash memory, or any other electric,magnetic, optical, or combination memory devices capable of storingdata, some of which represent executable instructions, used by thecontroller 394 in controlling components associated with the wearableinfusion port 102.

The instructions may include one or more separate programs, each ofwhich comprises an ordered listing of executable instructions forimplementing logical functions. The instructions, when executed by theprocessor 398, receive and process input signals, perform logic,calculations, methods and/or algorithms for controlling the componentsof the wearable infusion port 102, and generate control signals tocomponents of the wearable infusion port 102 to output one or morecontrol signals and/or data based on the logic, calculations, methods,and/or algorithms. Although only one controller 394 is shown in FIG. 4,embodiments of the wearable infusion port 102 can include any number ofcontrollers 394 that communicate over any suitable communication mediumor a combination of communication mediums and that cooperate to processthe sensor signals, perform logic, calculations, methods, and/oralgorithms, and generate control signals to control features of thewearable infusion port 102.

In various embodiments, one or more instructions of the controller 394are associated with the wearable infusion port 102 and, when executed bythe processor 398, the instructions receive and process signals from theglucose sensor 356 and determine a value of the blood glucose level ofthe user. In various embodiments, the instructions of the controller394, when executed by the processor 398, receive and process signalsfrom the flow sensor 298 and determine a volume of fluid or insulin thathas been dispensed by the valve assembly 114. In various embodiments,the instructions of the controller 394, when executed by the processor398, output one or more control signals to the valve assembly 114 tomove the valve assembly 114 from the closed state to the opened state todispense fluid or insulin to the user based on the blood glucose levelof the user. In various embodiments, the instructions of the controller394, when executed by the processor 398, output one or more controlsignals to the valve assembly 114 to move the valve assembly 114 fromthe opened state to the closed state based on the determined volume ofthe fluid or insulin dispensed.

The adhesive patch 122 couples the wearable infusion port 102 to theuser. The adhesive patch 122 is coupled to the second surface 112 a ofthe second housing 112 and affixes the second housing 112, and thus, thewearable infusion port 102, to an anatomy, such as the skin of the user.The adhesive patch 122 may be composed of a flexible and breathablematerial with one or more adhesive layers, such as cloth, a bandage-likematerial, and the like. For example, suitable materials could includepolyurethane, polyethylene, polyester, polypropylene,polytetrafluoroethylene (PTFE), or other polymers, to which one or moreadhesive layers are applied. The adhesive patch 122 may include abacking layer, which is removable to expose the one or more adhesivelayers.

In one example, with reference to FIG. 3, in order to assemble thewearable infusion port 102, the first housing 110 and the second housing112 may be formed. The adhesive patch 122 is coupled to the secondhousing 112 and the cannula assembly 116 may be assembled. Withreference to FIG. 7, with the flow sensor 298 and the flow sensorhousing 300 formed, the flow sensor 298 is positioned within the flowsensor housing 300 such that the sealing members 334 a, 334 b surroundthe respective one of the sensor inlet 330 and sensor outlet 332 tocreate a seal between the sensor inlet 330, the sensor outlet 332 andthe flow sensor housing 300. With the sealing band 306 coupled to thecannula plug 292 and the cannula 294 formed, the cannula plug 292 iscoupled to the cannula 294, and the cannula 294 is inserted into theflow sensor housing 300 such that the cannula sealing member 296 ispositioned between the flow sensor housing 300 and the cannula inlet326. The sealing member 346 is coupled to the flow sensor housing 300.The flow sensor housing 300 is coupled to the second housing 112, asshown in FIG. 4.

With reference to FIG. 5, the valve assembly 114 may be assembled. Inone example, with the actuator shaft 232 formed, the wire 260 may beinserted through the actuator shaft 232. The first post 256 and thesecond post 258 may be coupled to the wire 260. With the stator 164formed, the ratchet shim 162 is coupled to the stator 164. With therotor 160 formed, the rotor 160 is inserted into the stator 164. Theactuator shaft 232 is positioned within the stator 164. With theactuator pinion 236 formed, the actuator pinion 236 may be positionedwithin the stator 164. The actuator pinion 236 is received within thestator 164 such that the shaft teeth 244 engage the pinion teeth 268.The actuator shim 238 is coupled to the actuator pinion 236, and the endplate 240 is coupled to the shaft 175 of the rotor 160. With the valveassembly 114 assembled, the valve assembly 114 is coupled to the secondhousing 112 as shown in FIG. 4.

With reference to FIG. 8, the continuous glucose monitor assembly 118may also be assembled. In one example, with the second sensor housing358 formed, the glucose sensor 356 is positioned through the secondsensor housing 358. The electrical connection is established between theglucose sensor 356 and the outer sleeve 372. The sensor septum 354 ispositioned over the proximal end 356 b of the glucose sensor 356. Withthe first sensor housing 352 formed, the first sensor housing 352 ispositioned over the second sensor housing 358 to compress the sensorseptum 354. The sensor sealing member 350 is positioned within the sealgroove 362 of the first sensor housing 352.

With reference to FIG. 3, the control system 120 is assembled byelectrically and physically coupling the power supply 390, thecommunication device 392 and the controller 394 to the circuit board396. The power supply 390, the communication device 392 and the flowsensor 298 are each in communication with the controller 394. Thecircuit board 396 is coupled to the second housing 112. The flange 215is electrically and physically coupled to the circuit board 396 suchthat the wire 260 is in communication with the controller 394 to receivethe one or more control signals to heat the wire 260. The needle septum290 is positioned over the cannula plug 292. The first housing 110 iscoupled to the second housing 112. The continuous glucose monitorassembly 118 is coupled to the first housing 110, via the snap-fitengagement of the legs 366 with the endwall 130 b of the receivingprojection 130 (FIG. 4).

With the wearable infusion port 102 assembled, the wearable infusionport 102 may be packaged, sterilized and provided to an end user. Oncereceived, the user may remove the packaging to expose the wearableinfusion port 102. The user may remove the backing layer, if any, fromthe adhesive patch 122. The user may manipulate the insertion device(not shown) to deploy the wearable infusion port 102 onto the user suchthat the distal end 356 a of the glucose sensor 356 (FIG. 4) and thedistal end 324 of the cannula 294 (FIG. 4) are each positioned withinthe subcutaneous tissue of the user. The adhesive patch 122 couples thewearable infusion port 102 to the anatomy, such as the skin, of theuser.

With the wearable infusion port 102 coupled to the user, with referenceto FIG. 4, the user may dispense the fluid or insulin F into the firstneedle port 132. The fluid F flows from the first needle port 132 (whichis an inlet for the wearable infusion port 102) into the central bore180 of the rotor 160. With reference to FIG. 6, the valve assembly 114is shown in the closed state. In the closed state, the second post 258extends beyond the end 250 of the actuator shaft 232, and one of theconduits 194 of the conduit sleeve 170 is not aligned with the outletconduit 224. Based on the receipt of the one or more control signals (orpower) from the control system 120, with reference to FIG. 9, as thewire 260 begins to increase in temperature, which causes the wire 260 tocontract or move toward the stator 164. The contraction of the wire 260causes the second post 258 to contact the flange 254. The continuedcontraction of the wire 260 overcomes the spring force Fs (FIG. 5) andcauses the second post 258 to move the actuator shaft 232 linearly in adirection D toward the flange 215. The translation of the actuator shaft232 rotates the actuator pinion 236, which in turn, via the actuatorshim 238 and the end plate 240, rotates the rotor 160. In one example,the contraction of the wire 260 moves the rotor 160 about 20 degreescounterclockwise.

The rotation of the rotor 160 moves the conduit sleeve 170 until one ofthe conduits 194 aligns with the outlet conduit 224 as shown in FIG. 10.The valve assembly 114 is in the opened state in FIG. 10. With theconduit 194 aligned with the outlet conduit 224, the fluid flows fromthe rotor 160 to the outlet 220. Once the valve assembly 114 is in theopened state, the controller 394 outputs one or more control signals(removes the power) to the actuator shaft 232. With the power removed,the wire 260 cools. As the wire 260 cools, the spring force Fs of thespring 230 (FIG. 5) moves or translates the actuator shaft 232 back tothe first position (as shown in FIG. 6). The movement or translation ofthe actuator shaft 232 moves or rotates the actuator pinion 236clockwise to its original position (as shown in FIG. 6). In one example,the actuator pinion 236 moves or rotates about 20 degrees clockwise backinto the original position. The rotor 160, however, does not move orrotate with the actuator shaft 232 as the ratchet shim 162 and theactuator shim 238 inhibit the rotation of the shaft 175 clockwise.

With reference to FIG. 4, from the outlet 200, the fluid F flows intothe housing inlet conduit 336 of the flow sensor housing 300. From thehousing inlet conduit 336 the fluid F flows into the sensor inlet 330 ofthe flow sensor 298. The fluid F is heated by the heater 328, and thetemperature sensors 329 a, 329 b observe the temperature of the fluid F(FIG. 7). The fluid F flows into the sensor outlet 332 and from thesensor outlet 332 through the housing outlet conduit 338 of the flowsensor housing 300. From the housing outlet conduit 338, the fluid flowsthrough the band conduit 322 into the cannula plug 292, and into thecannula 294. The fluid F exits the distal end 324 of the cannula 294into the subcutaneous tissue.

The temperature sensors 329 a, 329 b communicate the sensor signals tothe controller 394. The controller 394 determines the volume of thefluid F dispensed based on the change in temperatures. Based on thedetermined volume dispensed, the controller 394 outputs one or morecontrol signals (or power) from the control system 120 to move the valveassembly 114 from the opened state to the closed state. With referenceto FIG. 9, as the wire 260 begins to increase in temperature, the wire260 contracts or move toward the stator 164. The contraction of the wire260 causes the second post 258 to contact the flange 254. The continuedcontraction of the wire 260 overcomes the spring force Fs (FIG. 5) andcauses the second post 258 to move the actuator shaft 232 linearly in adirection D toward the flange 215. The translation of the actuator shaft232 rotates the actuator pinion 236, which in turn, via the actuatorshim 238 and the end plate 240, rotates the rotor 160. In one example,the contraction of the wire 260 moves the rotor 160 about 20 degreescounterclockwise. As the conduits 194 are spaced about 40 degrees apart,the rotation of the rotor 160 about 20 degrees counterclockwise resultsin one of the conduits 194 being misaligned with the outlet conduit 224as shown in FIG. 6, which inhibits the flow of the fluid F through theoutlet 200.

Once coupled to the user, the control system 120 of the wearableinfusion port 102 communicates with the portable electronic device andmay send one or more notifications to the portable electronic device fordisplay on the portable electronic device, including, but not limitedto, blood glucose levels, a volume of insulin dispensed, etc. Inaddition, the control system 120 may also be able to determine when thewearable infusion port 102 is low or needs an additional quantity ofinsulin. For example, the rotor 160 may serve as a fluid reservoir,which may hold more fluid or insulin than necessary for a single dose.The processor 398 of the control system 120 may be configured todetermine, based on the sensor signals from the flow sensor 298 and aknown quantity of fluid or insulin that may be contained in the rotor160, a quantity or volume of the fluid or insulin remaining within thereservoir defined by the rotor 160. Based on this determination, thecontrol system 120 may be configured to output one or more notificationsto the user to dispense additional quantities of fluid into the wearableinfusion port 102. Generally, once coupled to the user, the wearableinfusion port 102 may be worn by the user for about 7 to about 10 days.

Thus, the wearable infusion port 102 enables a user to infuse a fluid,such as insulin, into the subcutaneous tissue of the user over anextended period of time without requiring the user to directly injectthe fluid into the anatomy of the user. This greatly reduces the numberof times the user has to insert a needle or pierced tip instrument intotheir anatomy, while providing the user with the necessary infusiontherapy. For users who require multiple injections of fluid or insulin aday, the user is subjected to a single insertion of the wearableinfusion port 102 instead of multiple insertions with needle syringes,etc. The wearable infusion port 102 also enables the user to monitortheir blood glucose levels via the remote device, and the control system120 of the wearable infusion port 102 and/or the remote device isconfigured to control the wearable infusion port 102 to dispense theinsulin based on the blood glucose levels. This can provide the userwith an experience similar to that provided by an infusion pump, with asmaller form factor. In addition, the use of the flow sensor 298 withthe wearable infusion port 102 may detect occlusions of the wearableinfusion port 102 (via a volume of fluid flow observed) and also ensuresthe delivery of the proper amount.

It should be noted that in other embodiments, the wearable infusion port102 may be configured differently to deliver fluid, such as insulin, toa user over an extended period of time. For example, with reference toFIG. 11, a wearable infusion port 500 is shown. As the wearable infusionport 500 includes the same or similar components as the wearableinfusion port 102 discussed with regard to FIGS. 1-10, the samereference numerals will be used to denote the same or similarcomponents. The wearable infusion port 500 is generally rectangular orsquare, however, it will be understood that the wearable infusion port500 may have any desired shape. In one example, with reference to FIG.12, the wearable infusion port 500 includes an upper or first housing510, a bottom or second housing 512, a valve assembly 514, a cannulaassembly 516, and a control system 520. The wearable infusion port 500may be coupled to the user via the adhesive patch 122.

The first housing 510 and the second housing 512 may be composed of asuitable biocompatible material, including, but not limited to abiocompatible polymer-based material, which may be molded, printed,cast, etc. The first housing 510 and the second housing 512 aresubstantially rectangular or square, however, the first housing 510 andthe second housing 512 may have any desired shape. The first housing 510and the second housing 512 cooperate to substantially enclose the valveassembly 514, the cannula assembly 516 and the control system 520. Withreference to FIGS. 13 and 13A, the first housing 510 defines a receivingbore 530, a first needle port 532 and a coupling interface 536. Thefirst housing 510 may also define a receiving projection 538 and asecond receiving projection 539 on a second surface 510 b.

With reference back to FIG. 13, the receiving bore 530 receives aportion of the cannula assembly 516 for coupling the cannula assembly516 to the first housing 510. Generally, the receiving bore 530 extendsinward, through a first surface 510 a of the first housing 510, towardthe second housing 512. The first surface 510 a is opposite the secondsurface 510 b. The receiving bore 530 is shown as cylindrical (FIG.13A), but may have any desired shape. The first needle port 532 isdefined through the first surface 510 a of the first housing 510, andenables a needless syringe, infusion pen or other device, such as thepump 104, to dispense fluid into the wearable infusion port 500. Thefirst needle port 532 is in fluid communication with the valve assembly514 to provide the fluid received through the first needle port 532 tothe valve assembly 514, as will be discussed. The first needle port 532defines an inlet for the wearable infusion port 500. The first needleport 532 includes a septum 531 and a conduit 533. The septum 531 isdisposed upstream from an inlet 533 a of the conduit 533. The septum 531serves to prevent the ingress and egress of fluids into/out of and intofirst needle port 532. The conduit 533 extends through the first housing510 from the first needle port 532 to the second surface 510 b. Theinlet 533 a is defined in the first housing 510 downstream of the septum531, and is in fluid communication with the first needle port 532. Theconduit 533 has an outlet 533 b downstream of the inlet 533 a. Theoutlet 533 b fluidly couples the first needle port 532 to the valveassembly 514 to provide the valve assembly 514 with the fluid orinsulin. The outlet 533 b in this example is defined through the secondsurface 510 b so as to extend along an axis transverse or substantiallyperpendicular to an axis that extends through the inlet 533 a.

The coupling interface 536 is defined about a perimeter of the firsthousing 510. The coupling interface 536 defines a sidewall 536 a, andincludes an interlock recess 537. The sidewall 536 a extends about theperimeter of the first housing 510, and extends from the first surface510 a generally so as to be substantially parallel to a center axis CAof the wearable infusion port 500. The sidewall 536 a cooperates withthe second housing 512 to substantially enclose the valve assembly 514,the cannula assembly 516 and the control system 520. The interlockrecess 537 is defined about a perimeter of the sidewall 536 a, and inone example, is a relief having a square notch 538 a. The square notch538 a interfaces with or interlocks with a corresponding feature on thesecond housing 512 to assist in coupling the first housing 510 to thesecond housing 512 with a waterproof seal. It should be understood,however, that the interlock recess 537 may not include the square notch538 a, but rather may define an endwall that is substantiallyperpendicular to the center axis CA (FIG. 2) or that a notch associatedwith the interlock recess 537 may have a different shape.

The receiving projection 538 is substantially cylindrical (FIG. 13A) andextends from the second surface 510 b toward the second housing 512. Thereceiving projection 538 assists in coupling the valve assembly 114between the first housing 510 and the second housing 512. The secondreceiving projection 539 is substantially cylindrical (FIG. 13A) andextends from the second surface 510 b toward the second housing 512. Thesecond receiving projection 539 also assists in coupling the valveassembly 114 between the first housing 510 and the second housing 512.

The second housing 512 is coupled to the first housing 510. Withreference to FIG. 12, the second housing 512 includes a second receivingprojection 540, a control receiving portion 544 and a valve receivingportion 546. The second receiving projection 540 cooperates with thereceiving bore 530 of the first housing 510 and the receiving projection538 to receive the cannula assembly 516. The second receiving projection540 defines a second bore 550 (FIG. 13). The second bore 150 is definedthrough the second housing 512. The second bore 150 enables a portion ofthe cannula assembly 116 to pass through the second housing 512 and intothe anatomy when the wearable infusion port 500 is coupled to a user.

With reference to FIG. 12, the control receiving portion 544 is definedalong a third surface 512 b of the second housing 512, which is oppositea second surface 512 a. In this example, the control receiving portion544 includes at least one or a pair of posts 544 a, which cooperate toretain a portion of the control system 520 within the second housing512. The control receiving portion 544 may also include power supplyribs 544 b, which assist in assembling a portion of the control system520 to the second housing 512. The valve receiving portion 546 includesa plurality of posts 546 a.

The valve assembly 514 receives the fluid for infusion, which is insulinin this example, and is movable between an opened state and a closedstate. In the closed state, insulin is not dispensed and in the openedstate, the insulin is dispensed. With reference to FIG. 14, a detailview of the valve assembly 514 is shown. In one example, the valveassembly 514 includes a flow sensor 562, a valve housing 564 and anactuator assembly 566.

With reference to FIG. 14, the flow sensor 562 is in fluid communicationwith the valve housing 564. The flow sensor 562 is in fluidcommunication with the valve housing 564 to observe or measure an amountof fluid or insulin received within the valve housing 564. The flowsensor 562 observes an amount of fluid that passes through the valvehousing 564 from the first needle port 532, and generates one or moresignals based on the observation. The flow sensor 562 is incommunication with the control system 520 to provide the control system520 with the sensor signals. In one example, the flow sensor 562observes a volume of the insulin that passes through the valve housing564 to the cannula assembly 516, through the cannula assembly 516 andinto the user. Thus, the flow sensor 562 observes a volume of the fluidor insulin that is received by the valve assembly 514. As will bediscussed, based on the signals received from the flow sensor 562, thecontrol system 520 may output one or more control signals to the valveassembly 514 to move the valve assembly 514 from the opened state to theclosed state.

In one example, the flow sensor 562 is a thermal mass flow sensor, whichdetects flow rates from about 1.0 to about 40.0 milliliters per minute(mL/min). In this example, the flow sensor 562 includes the heat sourceor heater 328 and the pair of temperature sensors 329 a, 329 b on eitherside of the heater 328. The heater 328 and the temperature sensors 329a, 329 b are coupled to or in communication with the flow conduit 331defined within the flow sensor 562. The heater 328 heats the fluid orinsulin as the fluid passes through the flow sensor 562. One of thetemperature sensors observe a first temperature of the fluid (prior toheating) and the other one of the temperature sensors observes a secondtemperature of the fluid (after heating). The signals from thetemperature sensors 329 a, 329 b are communicated to the control system520, and the control system 520 determines the volume of the fluiddelivered based on a difference between the two temperature signals.Thus, the flow sensor 562 is in communication with the control system520. The signals from the temperature sensors may be filtered, ifdesired, to account for turbulence. It should be noted, alternatively,the flow sensor 562 may also include a monitor module, which determinesthe volume based on the temperature signals, and transmits thedetermined volume to the control system 520.

In this example, the flow sensor 562 includes a sensor inlet 563 influid communication with the first needle port 532 (via the valvehousing 564) and a sensor outlet 565 in fluid communication with thevalve housing 564. A pair of sealing members (not shown) may be coupledabout a respective one of the sensor inlet 563 and the sensor outlet 565to provide a seal between the flow sensor 562 and the valve housing 564.In one example, the sealing members 334 a, 334 b are elastomericO-rings, however, other sealing mechanisms may be employed. In thisexample, the flow sensor 298 includes a separate housing 298 a, whichincludes the sensor inlet 330 and the sensor outlet 332, and alsocontains or encloses the temperature sensors 329 a, 329 a, the heater328 and the flow conduit 331. It should be noted that the flow sensor562 need not include a separate housing 562 a, but may be defined withinthe valve housing 564, if desired. The flow sensor 562 is generallypositioned between the valve housing 564 and the third surface 512 b ofthe second housing 512.

The valve housing 564 includes a cannula guide 568, an actuatorreceiving portion 570 and an inlet port 572. The cannula guide 568 iscylindrical and receives the cannula assembly 116. In one example, withreference to FIG. 13, the cannula guide 568 includes a groove 574 and acannula conduit 576. The groove 574 assists in coupling the valvehousing 564 to the first housing 510. The groove 574 has a diameter,which is different and, in this example, smaller than a diameter of theremainder of the cannula guide 568 to enable a sealing member 578 to bepositioned about the groove 574. The sealing member 578 forms a sealbetween the first housing 510 and the valve housing 564. In one example,the sealing member 578 is an elastomeric O-ring, however, other sealingmechanisms may be employed. The cannula conduit 576 is defined withinthe cannula guide 568 to fluidly couple the cannula assembly 116 to theactuator assembly 566. The cannula conduit 576 receives fluid or insulinfrom the actuator assembly 566 when the valve assembly 114 is in theopened state. The cannula conduit 576 includes an inlet 580 in fluidcommunication with the actuator assembly 566, and an outlet 582 in fluidcommunication with the cannula assembly 116.

The actuator receiving portion 570 receives the actuator assembly 566.In one example, the actuator receiving portion 570 includes an actuatorshaft receiving portion 584 and an actuator wire receiving portion 586(FIG. 14). The actuator shaft receiving portion 584 includes a sleeve588 and a first shaft conduit 590. With reference to FIG. 14, the sleeve588 receives a portion of the actuator assembly 566 and guides amovement of the portion of the actuator assembly 566 relative to thevalve housing 564. With reference back to FIG. 13, the first shaftconduit 590 includes a shaft inlet 592 and a shaft outlet 594. In thisexample, the first shaft conduit 590 is L-shaped such that the shaftinlet 592 extends along an axis that is transverse or substantiallyperpendicular to the shaft outlet 594; however, the first shaft conduit590 may have any desired shape. The shaft inlet 592 is in fluidcommunication with the sensor outlet 565 to receive the fluid from theflow sensor 562. The shaft outlet 594 is in fluid communication with theactuator assembly 566.

The inlet port 572 is defined in the valve housing 564 so as to fluidlycouple the first needle port 532 to the flow sensor 562. With referenceto FIG. 13, the inlet port 572 is substantially cylindrical and definesa second groove 596. The second groove 596 assists in coupling the valvehousing 564 to the first housing 510. The second groove 596 has adiameter, which is different and, in this example, smaller than adiameter of the remainder of the inlet port 572 to enable a secondsealing member 598 (FIG. 13) to be positioned about the groove 574. Withreference to FIG. 13, the second sealing member 598 forms a seal betweenthe first housing 510 and the valve housing 564. In one example, thesecond sealing member 598 is an elastomeric O-ring, however, othersealing mechanisms may be employed. The inlet port 572 also defines aport conduit 600 to fluidly couple the first needle port 532 to the flowsensor 562. The port conduit 600 receives fluid or insulin from thefirst needle port 532. The port conduit 600 includes a port inlet 602 influid communication with the outlet 533 b of the first needle port 532,and a port outlet 604 in fluid communication with the sensor inlet 563of the flow sensor 562.

The actuator assembly 566 is responsive to one or more control signalsfrom the control system 520 to move the valve assembly 514 between theopened state and the closed state. With reference to FIG. 14, theactuator assembly 566 includes the biasing member or spring 230, anactuator shaft 632 and an actuator wire system 634. As will bediscussed, a movement or translation of the actuator shaft 632 moves thevalve assembly 114 between the opened state and the closed state.

The spring 230 is coupled to an exterior surface 632 a of the actuatorshaft 632, and applies the spring force Fs against a collar 642 of theactuator shaft 632 to bias the actuator shaft 632 into a first position.When the actuator shaft 632 is in the first position, the valve assembly114 is in the closed state. The spring 230 is seated between the collar642 and the actuator shaft receiving portion 584 to apply the springforce Fs against the collar 642.

The actuator shaft 632 is cylindrical, and is received within theactuator shaft receiving portion 584. The actuator shaft 632 may becomposed of a suitable biocompatible material, such as a polymer-basedmaterial, metal or metal alloy, which is cast, molded, printed, stamped,etc. The actuator shaft 632 includes the collar 642, a second shaftconduit 646 and opposed ends 648, 650. The collar 642 is defined aboutthe exterior surface 632 a of the actuator shaft 632. The collar 642 isdefined to extend about the exterior surface 632 a at the end 648 of theactuator shaft 632. The collar 642 has a diameter, which is differentthan, and in this example, greater than a diameter of the end 650. Theend 650 is coupled to the wire 260. The end 650 may be overmolded overthe actuator wire system 634, or may be coupled to the wire 260 througha suitable processing step, including, but not limited to ultrasonicwelding, adhesives, etc.

The second shaft conduit 646 is defined through the actuator shaft 632.In one example, the second shaft conduit 646 is defined through theactuator shaft 632 so as to extend along an axis transverse orsubstantially perpendicular to a longitudinal axis of the actuator shaft632. The second shaft conduit 646 is defined through a portion of theactuator shaft 632 such that the second shaft conduit 646 is only influid communication with the shaft outlet 594 when the actuator shaft632 has moved or translated from the first position to a second positionin a direction D2 toward the second coupling post 658 (FIG. 14). Whenthe second shaft conduit 646 is in the second position, the valveassembly 514 is in the opened state. The second shaft conduit 646 has aninlet 646 a in fluid communication with the shaft outlet 594, and anoutlet 646 b in fluid communication with inlet 580 of the cannulaconduit 576. When the actuator shaft 632 is in the first position, thesecond shaft conduit 646 is not aligned with the first shaft conduit590, and thus, the valve assembly 514 is in the closed state, as shownin FIG. 16.

With reference to FIG. 14, the actuator wire system 634 is coupled tothe actuator shaft 632. The actuator wire system 634 includes a firstcoupling post 656, a second coupling post 658 opposite the firstcoupling post 656 and the wire 260. The first coupling post 656 and thesecond coupling post 658 are generally cylindrical, and have a diameterthat is greater than a diameter of the wire 260. The first coupling post656 and the second coupling post 658 may be composed of a suitableconductive material, such as a metal or metal alloy, which is cast,molded, printed, stamped, etc. The first coupling post 656 and thesecond coupling post 658 are physically and electrically coupled to thewire to provide an electric current to the wire. The first coupling post656 and the second coupling post 658 may be coupled to the wire 260 viawrapping of the wire 260 around the first coupling post 656 and thesecond coupling post 658, for example. The first coupling post 656 andthe second coupling post 658 are each in communication with the controlsystem 520 to receive one or more control signals, in this example, acurrent, to heat the wire 260.

As discussed, the wire 260 is a shape memory wire, and in one example,is a nitinol wire. Opposed ends of the wire 260 are coupled to arespective one of the first coupling post 656 and the second couplingpost 658. In this example, the control system 520 supplies the currentto the first coupling post 656, which passes through wire 260 to thesecond coupling post 658. The current is conducted by the wire 260,which causes the wire to increase in temperature. The increase intemperature of the wire 260 causes the wire 260 to move from the first,extended state to the second, contracted state. In the first, extendedstate, the wire 260 is elongated and the actuator shaft 632 is in thefirst position (the valve assembly 114 is in the closed state). In thesecond, contracted state, the wire 260 is contracted, which overcomesthe force Fs of the spring 230, and the actuator shaft 632 is in thesecond position (the valve assembly 114 is in the opened state). Thus,the increase in temperature of the wire 260 moves or translates theactuator shaft 632 from the first position to the second position (toopen the valve assembly 114). Once the current is removed from the wire260, the wire 260 decreases in temperature and the spring force Fs,along with the decrease in temperature, moves or translates the actuatorshaft 632 from the second position to the first position (to close thevalve assembly 114).

With reference to FIG. 15, the cannula assembly 516 is fluidly coupledto the outlet 582 of the cannula conduit 576 of the valve assembly 514to receive the fluid or insulin. The cannula assembly 516 receives thefluid or insulin from the valve assembly 514 and delivers the fluid tothe user. In one example, the cannula assembly 516 includes a needleseptum 690, a cannula plug 692, a cannula 694 and a second septum 696.The needle septum 690 is positioned in a plug conduit 698 of the cannulaplug 692. The needle septum 690 serves to prevent the ingress and egressof fluids into/out of the cannula plug 692. The needle septum 690 ispierceable by a piercing member of the insertion device (not shown) tocouple the cannula 694 to the user.

The cannula plug 692 couples the cannula 694 to the valve housing 564.The cannula plug 692 is received through the receiving bore 530 of thefirst housing 510 and extends from the first housing 510 through thecannula guide 568 of the valve housing 564 to the second septum 696. Thecannula plug 692 may be composed of a suitable biocompatible material,such as a polymer-based material, metal or metal alloy, which is cast,molded, printed, stamped, etc. In one example, the cannula plug 692includes a first plug end 702 opposite a second plug end 704, a sidewall708 and the plug conduit 698. The cannula plug 692 is substantiallycylindrical, and the first plug end 702 is connected to the second plugend 704 via the sidewall 708. The first plug end 702 is coupled to thefirst housing 510, and may include a flange 702 a that interfaces withthe second surface 512 a of the first housing 510. The needle septum 690is received at the first plug end 702. The second plug end 704 iscoupled to the cannula 694 and is positioned adjacent to the secondseptum 696. The second plug end 704 may be coupled to the cannula 694via overmolding, ultrasonic welding, adhesives, etc. The sidewall 708defines a cross conduit 712. The cross conduit 712 extends along an axistransverse or substantially perpendicular to a longitudinal axis L3 ofthe cannula assembly 516. The cross conduit 712 fluidly couples thevalve housing 564 to the cannula 694. The cross conduit 712 includes across inlet 714 in fluid communication with the outlet 582, and a crossoutlet 716 in fluid communication with the plug conduit 698. The crossconduit 712 receives the fluid or insulin from the cannula conduit 576and directs the fluid or insulin into the plug conduit 698 fordispensing to the user through the cannula 694. In this example, thecross conduit 712 is shown to extend through the cannula plug 692 from afirst side of the sidewall 708 to an opposed side of the sidewall 708,however, the cross conduit 712 may be formed from the sidewall 708 tothe plug conduit 698, if desired.

The plug conduit 698 is defined within the cannula plug 692 to extendalong the longitudinal axis L3 from the first plug end 702 to the secondplug end 704. The plug conduit 698 receives the needle from theinsertion device to couple the cannula 694 to the user, and alsoreceives the fluid or insulin from the cross conduit 712 to deliver thefluid to the user via the cannula 694. The plug conduit 698 includes afirst plug inlet 718, a second plug inlet 720 and a plug outlet 722. Theneedle septum 690 is coupled to the first plug inlet 718. The secondplug inlet 720 is fluidly coupled to the cross outlet 716 to receive thefluid or insulin from the valve housing 564. The plug outlet 722 isfluidly coupled to a proximal end 694 a of the cannula 694.

The second septum 696 is coupled or positioned between the second plugend 704 and the third surface 512 b of the second housing 512. Thesecond septum 696 is received within the second receiving projection 540of the second housing 512. In one example, the cannula 694 passesthrough the second septum 696 such that the second septum 696 surroundsthe cannula 694. The second septum 696 serves to prevent the ingress andegress of fluids around the cannula 694. An additional septum 697 may becoupled to a slot 699 defined in the valve housing 564 to inhibit theingress/egress of fluid into the control system 520.

The cannula 694 is coupled to the second plug end 704 of the cannulaplug 692, and is configured to be inserted into the subcutaneous tissueof a user via the insertion device (not shown). The cannula 694 is ahollow tubular structure, and includes the proximal end 694 a and thedistal end 324. The proximal end 694 a is coupled to the second plug end704 to couple the cannula 294 to the cannula plug 292. The proximal end694 a defines a cannula inlet 726. The cannula inlet 726 is fluidlycoupled to the cannula plug 692 to receive the fluid or insulin from thevalve housing 564. The distal end 324 may be blunt or pointed, and isconfigured to be inserted into the subcutaneous tissue of the user whenthe wearable infusion port 500 is coupled to the user.

With reference to FIG. 17, the control system 520 includes a powersupply 750, the communication device 392 and a controller 752. In oneexample, the power supply 750, the communication device 392 and thecontroller 752 are physically and electrically coupled together via acircuit board 754. The circuit board 754 may be coupled to the posts 544a to support the circuit board 754 above the third surface 512 b of thesecond housing 512. The circuit board 754 may be electrically coupled tothe flow sensor 562 via one or more electrical contacts 577 coupled tothe second housing 512 (FIG. 12), however, other techniques may beemployed to electrically couple the flow sensor 562 to the controller752. The power supply 750 supplies power to the controller 752, which inturn supplies power to the wire 260, the flow sensor 562 and thecommunication device 392. In one example, the power supply 750 comprisesthe pair of coin cell batteries 390 a, 390 b, which are electricallycoupled to the circuit board 754 via battery contact pads 758, 759 (FIG.12). It should be noted, however, that any suitable power supply 750 maybe employed with the control system 520, including, but not limited to,rechargeable batteries, solar cells, etc.

The communication device 392 enables wireless communication between thewearable infusion port 102 and the remote device or portable electronicdevice associated with the user, including, but not limited to a cellphone, tablet, personal computer, smart watch, smart glasses, infusionpump, etc. The communication device 392 enables the controller 752 ofthe wearable infusion port 500 to communicate data, such as the volumeof fluid dispensed by the valve assembly 514 (as observed by the flowsensor 298), etc. The communication device 392 also enables thecontroller 394 to receive data, such as one or more commands for thecontroller 752 to dispense a volume of the fluid or insulin to the userfrom the portable electronic device, for example.

The controller 752 includes at least one processor 756 and a computerreadable storage device or media 760. The processor 756 can be anycustom made or commercially available processor, a central processingunit (CPU), a graphics processing unit (GPU), an auxiliary processoramong several processors associated with the controller 752, asemiconductor based microprocessor (in the form of a microchip or chipset), a macroprocessor, any combination thereof, or generally any devicefor executing instructions. The computer readable storage device ormedia 760 may include volatile and nonvolatile storage in read-onlymemory (ROM), random-access memory (RAM), and keep-alive memory (KAM),for example. KAM is a persistent or non-volatile memory that may be usedto store various operating variables while the processor 756 is powereddown. The computer-readable storage device or media 760 may beimplemented using any of a number of known memory devices such as PROMs(programmable read-only memory), EPROMs (electrically PROM), EEPROMs(electrically erasable PROM), flash memory, or any other electric,magnetic, optical, or combination memory devices capable of storingdata, some of which represent executable instructions, used by thecontroller 752 in controlling components associated with the wearableinfusion port 500.

The instructions may include one or more separate programs, each ofwhich comprises an ordered listing of executable instructions forimplementing logical functions. The instructions, when executed by theprocessor 756, receive and process input signals, perform logic,calculations, methods and/or algorithms for controlling the componentsof the wearable infusion port 500, and generate control signals tocomponents of the wearable infusion port 500 to output one or morecontrol signals and/or data based on the logic, calculations, methods,and/or algorithms. Although only one controller 752 is shown in FIG. 17,embodiments of the wearable infusion port 500 can include any number ofcontrollers 752 that communicate over any suitable communication mediumor a combination of communication mediums and that cooperate to processthe sensor signals, perform logic, calculations, methods, and/oralgorithms, and generate control signals to control features of thewearable infusion port 500.

In various embodiments, one or more instructions of the controller 752are associated with the wearable infusion port 500 and, when executed bythe processor 756, the instructions receive and process signals from theflow sensor 562 and determine a volume of fluid or insulin that has beenreceived by the valve assembly 514. In various embodiments, theinstructions of the controller 752, when executed by the processor 756,output one or more control signals to the valve assembly 514 to move thevalve assembly 514 from the closed state to the opened state to dispensefluid or insulin to the user based on one or more control signalsreceived from the portable electronic device. In various embodiments,the instructions of the controller 752, when executed by the processor756, output one or more control signals to the valve assembly 514 tomove the valve assembly 514 from the opened state to the closed statebased on the determined volume of the fluid or insulin received.

The adhesive patch 122 couples the wearable infusion port 102 to theuser. The adhesive patch 122 is coupled to the second surface 512 a ofthe second housing 512 and affixes the second housing 512, and thus, thewearable infusion port 500, to an anatomy, such as the skin of the user.The adhesive patch 122 may include the backing layer, which is removableto expose the one or more adhesive layers.

In one example, with reference to FIG. 12, in order to assemble thewearable infusion port 500, the first housing 510 and the second housing512 may be formed. The adhesive patch 122 is coupled to the secondhousing 512 and the valve assembly 514 may be assembled. In one example,with reference to FIG. 14, with the valve housing 564 formed, the wire260 may be coupled to the end 650 of the actuator shaft 632. The spring230 is coupled about the actuator shaft 632 proximate the end 648, andthe actuator shaft 632 is inserted through the actuator shaft receivingportion 584. The wire 260 is coupled to the first coupling post 656 andthe second coupling post 658. The flow sensor 562 is coupled to thevalve housing 564. The second septum 696 is coupled to the secondhousing 512. The valve housing 564 is coupled to the second housing 512.

The control system 520 is assembled by electrically and physicallycoupling the power supply 750, the communication device 392 and thecontroller 752 to the circuit board 754. The power supply 750 and thecommunication device 392 are each in communication with the controller752. The circuit board 754 is coupled to the second housing 512 and theflow sensor 562 is electrically coupled to the circuit board 754. Thesealing members 598, 578 are coupled to the valve housing 564. The firsthousing 510 is coupled to the second housing 512. With reference to FIG.15, with the cannula plug 692 formed, the cannula 694 is coupled to thecannula plug 692. The needle septum 690 is coupled to the plug conduit698, and the cannula assembly 116 is inserted into the first housing 510and the valve housing 564 such that the second plug end 704 is coupledto the needle septum 690.

With the wearable infusion port 500 assembled, the wearable infusionport 500 may be packaged, sterilized and provided to an end user. Oncereceived, the user may remove the packaging to expose the wearableinfusion port 500. The user may remove the backing layer, if any, fromthe adhesive patch 122. The user may manipulate the insertion device(not shown) to deploy the wearable infusion port 500 onto the user suchthat the distal end 324 of the cannula 694 is positioned within thesubcutaneous tissue of the user. The adhesive patch 122 couples thewearable infusion port 500 to the anatomy, such as the skin, of theuser.

With the wearable infusion port 500 coupled to the user, with referenceto FIG. 4, the user may dispense the fluid or insulin F into the firstneedle port 532. The fluid F flows from the first needle port 532 intothe port conduit 600 of the valve housing 564. From the port conduit600, the fluid F flows into the sensor inlet 563 of the flow sensor 562.The fluid F is heated by the heater 328, and the temperature sensors 329a, 329 b observe the temperature of the fluid F. The fluid F flows intothe sensor outlet 565 and from the sensor outlet 565 the fluid flowsinto the first shaft conduit 590. With reference to FIG. 16, the valveassembly 514 is shown in the closed state. In the closed state, thesecond shaft conduit 646 defined in the actuator shaft 632 is notaligned or is not fluidly coupled to the first shaft conduit 590, andthus, the fluid received from the first needle port 532 cannot flowthrough the cannula 694. Based on the receipt of the one or more controlsignals (or power) from the control system 520, with reference to FIG.14, the wire 260 begins to increase in temperature, which causes thewire 260 to contract or move toward the second coupling post 658. Thecontraction of the wire 260 overcomes the spring force Fs and causes theactuator shaft 632 to move or translate linearly toward the secondposition in the direction D2 toward the second coupling post 658. Withreference to FIG. 15, the translation of the actuator shaft 632 movesthe second shaft conduit 646 into alignment with the first shaft conduit590 such that the first shaft conduit 590 is fluidly coupled to thesecond shaft conduit 646 to enable the fluid F to flow through theactuator shaft 632 and into the cannula conduit 576. In FIG. 15, thevalve assembly 514 is in the opened state. From the cannula conduit 576,the fluid F flows into the cross conduit 712, and from the cross conduit712 into the plug conduit 698. From the plug conduit 698 the fluid Fflows into the cannula 694 and into the subcutaneous tissue of the user.

The flow sensor 562 observes the fluid F that flows into the wearableinfusion port 500, and the processor 756 of the controller 752determines the volume of fluid received through the first needle port532 based on the sensor signals from the flow sensor 298. Based on thevolume of fluid F, the processor 756 of the controller 752 outputs oneor more control signals (removes the power) to the wire 260. With thepower removed, the wire 260 cools. As the wire 260 cools, the springforce Fs of the spring 230 (FIG. 14) moves or translates the actuatorshaft 632 back to the first position (as shown in FIG. 16). The movementor translation of the actuator shaft 632 moves the second shaft conduit646 out of alignment with the first shaft conduit 590, and therebyinhibits fluid communication between the valve housing 564 and thecannula 694.

Once coupled to the user, the control system 520 of the wearableinfusion port 102 communicates with the portable electronic device andmay send one or more notifications to the portable electronic device fordisplay on the portable electronic device, including, but not limitedto, a volume of insulin dispensed, etc. In addition, the control system520 may also be able to determine when the wearable infusion port 500 islow or needs an additional quantity of insulin. For example, the inletport 572 of the valve housing 564 may serve as a fluid reservoir, whichmay hold more fluid or insulin than necessary for a single dose. Theprocessor 756 of the control system 520 may be configured to determine,based on the sensor signals from the flow sensor 562 and a knownquantity of fluid or insulin that may be contained in the inlet port 572of the valve housing 564, a quantity or volume of the fluid or insulinremaining within the reservoir defined by the inlet port 572. Based onthis determination, the control system 520 may be configured to outputone or more notifications to the user to dispense additional quantitiesof fluid into the wearable infusion port 500. Generally, once coupled tothe user, the wearable infusion port 500 may be worn by the user forabout 7 to about 10 days.

Thus, the wearable infusion port 500 enables a user to infuse a fluid,such as insulin, into the subcutaneous tissue of the user over anextended period of time without requiring the user to directly injectthe fluid into the anatomy of the user. This greatly reduces the numberof times the user has to insert a needle or pierced tip instrument intotheir anatomy, while providing the user with the necessary infusiontherapy. For users who require multiple injections of fluid or insulin aday, the user is subjected to a single insertion of the wearableinfusion port 500 instead of multiple insertions with needle syringes,etc. The remote device may communicate with the control system 120 ofthe wearable infusion port 500 to control the wearable infusion port 500to dispense the insulin. This can provide the user with an experiencesimilar to that provided by an infusion pump, with a smaller formfactor. In addition, the use of the flow sensor 562 with the wearableinfusion port 500 may detect occlusions of the wearable infusion port500 (via a volume of fluid flow observed) and also ensures the deliveryof the proper amount.

The pump 104 may be used with either one the wearable infusion port 102and the wearable infusion port 500 to provide fluid, such as insulin, tothe respective one of the wearable infusion port 102 and the wearableinfusion port 500. It should be noted that the pump 104 may be used toprovide fluid, such as insulin, to various other ports associated withmedical devices, and thus, the use of the pump 104 with the wearableinfusion port 102 and the wearable infusion port 500 is merely anexample. In this example, the pump 104 is substantially circular;however, the pump 104 may have any desired shape. In one example, withreference to FIG. 18, the pump 104 includes a first pump housing 800, aplunger assembly 802, a biasing member or torsion spring 804 and a locksystem 806. The torsion spring 804 and the lock system 806 cooperate todefine an actuator system 809 for the pump 104. Although not illustratedherein, it should be understood that in certain embodiments, the pump104 may also include a cap, cover, plug or the like, which cooperateswith the first pump housing 800 to enclose the plunger assembly 802, thetorsion spring 804 and the lock system 806, without obstructing theoperation of a cannula assembly 834, described below.

The first pump housing 800 may be composed of a suitable biocompatiblematerial, including, but not limited to a biocompatible polymer-basedmaterial, which may be molded, printed, cast, etc. The first pumphousing 800 is substantially circular, however, the first pump housing800 may have any desired shape. The first pump housing 800 is coupled tothe plunger assembly 802, the torsion spring 804 and the lock system806. In one example, the first pump housing 800 defines at least onefluid reservoir 810 and an actuator chamber 812. In this example, thefirst pump housing 800 defines a plurality of fluid reservoirs, which inthis example is two fluid reservoirs 810 a, 810 b; however, the firstpump housing 800 may have any number of fluid reservoirs 810. The fluidreservoirs 810 a, 810 b are spaced apart about a perimeter orcircumference of the first pump housing 800, and in this example areabout 180 degrees apart along the circumference of the first pumphousing 800. Thus, in this example, the fluid reservoirs 810 a, 810 bare on opposed sides of the first pump housing 800. The fluid reservoirs810 a, 810 b, in this example, are integrally formed with and fixed tothe first pump housing 800, and are not removable or replaceable.

With reference to FIG. 19, each of the fluid reservoirs 810 a, 810 binclude a first reservoir end 814 and a second reservoir end 816opposite the first reservoir end 814. The first reservoir end 814 iscircumferentially open to receive a portion of the plunger assembly 802therethrough. The second reservoir end 816 is circumferentially closed(FIG. 22). The fluid, such as insulin, is contained within each of thefluid reservoirs 810 a, 810 b in a fluid chamber 811 that is defined byeach of the fluid reservoirs 810 a, 810 b between the first reservoirend 814 and the second reservoir end 816. As will be discussed, theplunger assembly 802 is received within each of the fluid reservoirs 810a, 810 b, and is movable within the fluid reservoirs 810 a, 810 b todispense the fluid from the pump 104. In this example, the firstreservoir end 814 of the fluid reservoir 810 b is aligned with or facesthe second reservoir end 816 of the fluid reservoir 810 a about thecircumference of the first pump housing 800, and the first reservoir end814 of the fluid reservoir 810 a is aligned with or faces the secondreservoir end 816 of the fluid reservoir 810 b. By positioning the firstreservoir ends 814 in opposed directions about the perimeter of thefirst pump housing 800, the plunger assembly 802 is able to move in asingle direction and dispense fluid from each of the fluid reservoirs810 a, 810 b, as will be discussed herein. Generally, the fluidreservoirs 810 a, 810 b are pre-filled with the fluid or insulin and arenot refillable such that the pump 104 is a disposable, consumablecomponent.

With to FIG. 18, the actuator chamber 812 includes a central post 818and a retaining flange 820. The central post 818 receives a portion ofthe plunger assembly 802. In this example, the central post 818 includesone or more keyed projections 822, which cooperate with correspondingkeyed grooves 824 on a portion of the lock system 806 to couple the locksystem 806 to the central post 818. The keyed projections 822 and thekeyed grooves 824 inhibit a rotation of the lock system 806 relative tothe first pump housing 800. The keyed projections 822 and the keyedgrooves 824 also direct a translational movement of the lock system 806relative to the first pump housing 800 as will be discussed furtherherein. The retaining flange 820 couples the plunger assembly 802 to thefirst pump housing 800. In one example, the retaining flange 820includes opposed lips 826, which cooperate with the plunger assembly 802to guide a rotation of the plunger assembly 802 relative to the firstpump housing 800.

The plunger assembly 802 is movable or rotatable relative to the firstpump housing 800 to dispense fluid substantially simultaneously fromeach of the fluid reservoirs 810 a, 810 b. In one example, the plungerassembly 802 includes a plunger base 830 and at least one plunger arm832. In this example, the plunger assembly 802 includes a plurality ofplunger arms, which in this case is two plunger arms 832 a, 832 b. Itshould be noted, however, that the plunger assembly 802 may include anynumber of plunger arms 832 that correspond with the number of fluidreservoirs 810. The plunger base 830 and the plunger arms 832 a, 832 bmay be composed of a suitable biocompatible material, including, but notlimited to a biocompatible polymer-based material, which may be molded,printed, cast, etc. The plunger arms 832 a, 832 b may be separately orintegrally formed with the plunger base 830. A side view of the plungerassembly 802 is shown in FIG. 20B.

In this example, the plunger base 830 is circular, however the plungerbase 830 may have any shape that corresponds to the shape of the firstpump housing 800. In one example, the plunger base 830 includes thecannula assembly 834, at least one guide flange 836 and a base conduit838 (FIG. 21). The cannula assembly 834 is received within a centralbore 840 defined through the plunger base 830. The plunger base 830 andthe cannula assembly 834 may be composed of a suitable biocompatiblematerial, including, but not limited to a biocompatible polymer-basedmaterial, which may be molded, printed, cast, etc. The cannula assembly834 may be coupled to the plunger base 830 via overmolding, adhesives,ultrasonic welding, laser welding, press-fit, etc. The central bore 840extends along a central axis CA of the pump 104. The central bore 840defines a notch 840 a (FIG. 18), which assists in coupling the cannulaassembly 834 to the plunger base 830. In one example, the plunger base830 also defines a pair of cut-outs 842 about a portion of a perimeteror circumference of the central bore 840 and a plunger lock surface 841(FIG. 20A). The cut-outs 842 provide a mass savings, and aresubstantially crescent-shaped. The cut-outs 842 are defined to extendabout the central bore 840 from either side of the base conduit 838(FIG. 21). With reference to FIG. 20A, the plunger lock surface 841 isdefined proximate the cut-outs 842, and is defined to extend about aperimeter or a circumference of an area adjacent to an annular flange835. In one example, the plunger lock surface 841 includes a pluralityof teeth 841 a, which cooperate to engage with a corresponding pluralityof teeth 915 a defined on the lock plate 910. The engagement between theteeth 841 a, 915 a maintains the plunger assembly 802 in the second,locked position. The annular flange 835 extends outwardly from theplunger base 830, and surrounds the cannula assembly 834. The annularflange 835 is sized and shaped to receive the lock plate 910. A firstside 835 a of the annular flange 835 is selectively coupled to thetorsion spring 804 via the lock system 806, and a second side 835 b ofthe annular flange 835 (opposite the first side 868) is proximate thelock system 806. The plunger base 830 also defines a second pair ofcut-outs 844. The second pair of cut-outs 844 are substantiallyrectangular, and are defined through the plunger base 830 proximate theat least one guide flange 836.

The cannula assembly 834 is configured to be coupled to the wearableinfusion port 102, 500 to transfer the fluid received from the fluidreservoirs 810 a, 810 b to the wearable infusion port 102, 500. In oneexample, the cannula assembly 834 includes a cannula coupling portion850 and a cannula 852. The cannula coupling portion 850 is substantiallycylindrical, and defines a coupling flange 854, a conduit 856 (FIG. 21)and a central cannula bore 858 (FIG. 21). The cannula coupling portion850 has a first end 850 a and an opposed second end 850 b. The first end850 a and the second end 850 b each extend a distance beyond arespective surface of the plunger base 830. The second end 850 bgenerally extends the distance beyond the surface of the plunger base830 to receive an external force Fe. With reference to FIG. 21, thecoupling flange 854 is defined about a perimeter or circumference of thecannula coupling portion 850 and in one example, includes a groove 851.The groove 851 is configured to form an interference fit with thecorresponding notch 840 a defined in the central bore 840. Theinterference fit also forms a seal between the plunger base 830 and thecannula assembly 834. The conduit 856 is defined through the couplingflange 854 to fluidly couple the cannula 852 to the base conduit 838.The conduit 856 is defined along an axis that is transverse orsubstantially perpendicular to the central axis CA. In one example, withbrief reference to FIG. 20, the conduit 856 includes a branch 856 adefined through the coupling flange 854 at a first end to extend to thecentral cannula bore 858, and a branch 856 b defined through thecoupling flange 854 at an opposed second end to extend to the centralcannula bore 858. It should be noted that the number of branches 856 a,856 b of the conduit 856 may be based on the number of plunger arms 832,and thus, the use of two branches 856 a, 856 b is merely an example.Each of the branches 856 a, 856 b includes a branch inlet 857 in fluidcommunication with the respective base branches 838 a, 838 b, and abranch outlet 859 in fluid communication with the central cannula bore858.

The central cannula bore 858 is defined through the cannula couplingportion 850 along the central axis CA. The central cannula bore 858fluidly couples the cannula 852 to the conduit 856. The central cannulabore 858 is defined through the cannula coupling portion 850 from thefirst end 850 a to the second end 850 b. With reference to FIG. 21, thecentral cannula bore 858 includes a septum 860 received proximate thefirst end 850 a, which serves to prevent the ingress and egress offluids into/out of the central cannula bore 858. The central cannulabore 858 has a pair of inlets 862 defined between the first end 850 aand the second end 850 b. Each of the inlets 862 receives the fluid fromthe respective branch outlet 859 of the branches 856 a, 856 b, anddirects the fluid from the branches 856 a, 856 b into the cannula 852.

The cannula 852 is received within the second end 850 b of the cannulacoupling portion 850. The cannula 852 is cylindrical and hollow, has aproximal end 864 and an opposite distal end 866. The proximal end 864 isfluidly coupled to the inlets 862. The distal end 866 may be blunt orpointed, and is configured to be inserted into the first needle port 132of the wearable infusion port 102 or the first needle port 532 of thewearable infusion port 500 to deliver the fluid to the respectivewearable infusion port 102, 500.

The at least one guide flange 836 is defined on the plunger base 830 ona first surface 830 a of the plunger base 830, and the first surface 830a is opposite a second surface 830 b. In this example, with reference toFIG. 20A, the at least one guide flange 836 comprises two guide flanges836 a, 836 b, which are spaced apart about a perimeter or circumferenceof the plunger base 830. The guide flanges 836 a, 836 b projectoutwardly from the first surface 830 a, and define a lip 837. The lip837 of the first side 868 of each of the guide flanges 836 a, 836 b iscoupled to a respective one of the lips 826 of the retaining flange 820when the plunger assembly 802 is in a first, unlocked position andengaged with the torsion spring 804. The lip 837 of the first side 868of the guide flanges 836 a, 836 b is unengaged with or spaced apart fromthe retaining flange 820 when the plunger assembly 802 is in the second,locked position. With reference back to FIG. 21, the engagement of thelip 837 of the first side 868 of each of the guide flanges 836 a, 836 bwith the retaining flange 820 guides a movement or rotation of theplunger base 830 relative to the first pump housing 800.

The base conduit 838 is defined from the respective one of the plungerarms 832 a, 832 b, and extends from the respective one of the plungerarms 832 a, 832 b to the respective one of the branches 856 a, 856 b ofthe central cannula bore 858 to fluidly couple the plunger arms 832 a,832 b to the cannula 852 (FIG. 20C). Thus, in this example, the baseconduit 838 includes two base branches 838 a, 838 b (FIG. 20C). Itshould be noted that the number of base branches 838 a, 838 b isdirectly proportional to the number of plunger arms 832 to enable fluidcommunication between the plunger arms 832 and the cannula 852. Each ofthe base branches 838 a, 838 b include a base inlet 872 in fluidcommunication with the respective plunger arm 832 a, 832 b, and a baseoutlet 874 in fluid communication with the respective branch inlet 857of the branches 856 a, 856 b of the cannula coupling portion 850 toreceive the fluid from the plunger arms 832 a, 832 b and deliver thefluid to the cannula 852.

With reference to FIG. 20, the plunger arms 832 a, 832 b are on opposedsides of the plunger base 830, and are coupled to the plunger base 830at a perimeter or circumference of the plunger base 830. In contrast,the cannula 852 is coupled proximate or at a center of the plunger base830. Each of the plunger arms 832 a, 832 b include a base connector 880,a plunger body 882 and a plunger 884. In this example, the plunger arms832 a, 832 b are coupled to the plunger base 830 with the baseconnectors 880 such that the base connector 880 of the plunger arm 832 afaces the plunger 884 of the plunger arm 832 b. Thus, the plunger arms832 are asymmetric with respect to the central axis CA. Each of the baseconnectors 880 couple the plunger arms 832 a, 832 b to the plunger base830, and fluidly couple the plunger arms 832 a, 832 b to the respectiveone of the base branches 838 a, 838 b. Each of the base connectors 880include a connector 886 and a cylindrical cap 888. The connector 886couples each of the plunger arms 832 a, 832 b physically and fluidly tothe plunger base 830. Each connector 886 includes a connector conduit890, which is in fluid communication with the respective one of the basebranches 838 a, 838 b (FIG. 20C). Each connector conduit 890 includes aninlet 892 in fluid communication with the respective plunger body 882,and an outlet 894 in fluid communication with a respective base inlet872 of the base branches 838 a, 838 b. The connector conduit 890 may besubstantially L-shaped to direct the fluid from the plunger body 882 tothe base branches 838 a, 838 b. The caps 888 are each configured toenclose the fluid reservoirs 810 a, 810 b when the plunger arms 832 a,832 b are fully received within the respective one of the fluidreservoirs 810 a, 810 b. Each cap 888 has a diameter, which isdifferent, and in this example, greater than a diameter of the plungerbody 882.

The plunger body 882 extends between the base connector 880 and theplunger 884. In this example, the plunger body 882 is arcuate to followthe curvature of the fluid reservoirs 810 a, 810 b; however, the plungerbody 882 may have any desired shape that corresponds with the fluidreservoirs 810 a, 810 b. For example, the plunger body 882 issubstantially cross-shaped in cross-section, however, the plunger body882 may have any desired cross-sectional shape, including circular,square, rectangular, etc. The plunger body 882 has a diameter that isdifferent, and in this example, less than a diameter of the cap 888.Each of the plunger bodies 882 have a first end 896 opposite a secondend 898, and define a body conduit 900 from the first end 896 to thesecond end 898. The first end 896 is coupled to the base connector 880,and the second end 898 is coupled to the plunger 884. The plunger bodies882 are cantilevered relative to the base connectors 880. The second end898 of the plunger bodies 882 may be bulbous to receive the plunger 884.Generally, each second end 898 has a diameter, which is different, andin this example, greater than the diameter of the plunger body 882.

Each of the body conduits 900 direct the fluid out of the respectivefluid reservoir 810 a, 810 b into the plunger base 830, and thus, thecannula 852 (FIG. 20C). Each body conduit 900 includes an inlet 902 andan outlet 904. The inlet 902 is fluidly coupled to the respectiveplunger 884 to receive the fluid from the fluid reservoir 810 a, 810 b.The outlet 904 is fluidly coupled to the inlet 892 of the base connector880 to direct the fluid from the fluid reservoirs 810 a, 810 b to thebase branches 838 a, 838 b.

Each plunger 884 surrounds the second end 898 of the respective plungerbody 882. The plunger 884 is substantially spherical, and defines acentral chamber 884 a, which enables the plunger 884 to be receivedabout the second end 898 to enclose the second end 898. Each plunger 884defines an inlet 906, which receives the fluid from the respective fluidreservoir 810 a, 810 b. The inlet 906 is fluidly coupled to the inlet902 of the respective plunger body 882 to direct the fluid from therespective fluid reservoir 810 a, 810 b through the plunger assembly 802and into the cannula 852 (FIG. 20C). Each plunger 884 may be composed ofa biocompatible polymer-based material, which may be cast, molded, etc.and coupled to the second end 898. The plunger 884 may also beovermolded onto the second end 898 of the respective plunger body 882,or may be integrally formed with the respective plunger body 882. Theplunger 884 is generally sized to have a diameter, which is about thesame as the diameter of the respective fluid reservoir 810 a, 810 b sothat the plungers 884 form a seal along the side of the fluid reservoir810 a, 810 b. The seal formed by the plungers 884 within the respectivefluid reservoir 810 a, 810 b ensures that the fluid is dispensed fromthe fluid reservoirs 810 a, 810 b via the inlet 906, and inhibitsleaking of the fluid about the plunger 884. Further, the seal formed bythe plungers 884 results in an increase in pressure within the fluidreservoirs 810 a, 810 b as the plunger arms 832 a, 832 b advance withinthe fluid reservoirs 810 a, 810 b, which assists in the dispensing ofthe fluid from the fluid reservoirs 810 a, 810 b into the plungerassembly 802, and thus, the cannula 852.

The torsion spring 804 is coupled between the retaining flange 820 ofthe first pump housing 800 and the annular flange 835 of the plungerbase 830 (FIG. 21). The torsion spring 804 is composed of a metal ormetal alloy, such as a spring steel, and may be shaped to form thetorsion spring 804. When the plunger assembly 802 is in the first,unlocked position, the torsion spring 804 applies a torque about thecentral axis CA to a first side 835 a of the annular flange 835 to moveor rotate the plunger base 830, and thus, the plunger arms 832 relativeto the first pump housing 800 to dispense the fluid. Thus, the torsionspring 804 moves the plunger assembly 802 in a first direction, which inthis example is counterclockwise, to dispense the fluid from the fluidreservoirs 810 a, 810 b. When the first side 835 a of the annular flange835 is spaced apart from the torsion spring 804 by the lock system 806,the plunger arms 832 are inhibited from moving to dispense the fluid.The advancement of the plunger arms 832 a, 832 b within the fluidreservoirs 810 a, 810 b pressurize the fluid reservoirs 810 a, 810 b anddispense the fluid from the fluid reservoirs 810 a, 810 b. In thesecond, locked position, the torsion spring 804 is inhibited fromapplying the torque to the plunger assembly 802.

The lock system 806 moves the plunger assembly 802 between the first,unlocked position (in which fluid or insulin flows from the fluidreservoirs 810 a, 810 b) and a second, locked position (in which fluidis inhibited from flowing from the fluid reservoirs 810 a, 810 b). Inone example, with reference to FIG. 20, the lock system 806 includes alock plate 910 and a lock spring 912. The lock plate 910 is annular, andincludes a first plate side 914 opposite a second plate side 916. Thelock plate 910 also defines a plate bore 918 through the first plateside 914 and the second plate side 916. The lock plate 910 may becomposed of a suitable biocompatible material, including, but notlimited to a biocompatible polymer-based material, metal or metal alloy,which may be molded, printed, cast, stamped, etc. The first plate side914 and the second plate side 916 are substantially planar or flat. Withreference to FIG. 20, the first plate side 914 includes a plate locksurface 915. In this example, the plate lock surface 915 is definedabout a perimeter or circumference of the lock plate 910 and includesthe plurality of teeth 915 a. The plurality of teeth 915 a cooperatewith the plurality of teeth 841 a to lock the plunger assembly 802, andthus, the pump 104 in the second, locked position. As shown in FIG. 21,the second plate side 916 includes a collar 916 a, which assists inaligning the lock spring 912 relative to the first pump housing 800. Theplate bore 918 defines the keyed grooves 824, which engage with thekeyed projections 822 of the first pump housing 800 to couple the lockplate 910 to the first pump housing 800.

The lock spring 912 is a wave spring, which biases the lock plate 910into the plunger assembly 802 to position the plunger assembly 802 inthe second, locked position (FIG. 24). The lock spring 912 is composedof a metal or metal alloy, such as a spring steel, and may be shaped toform the lock spring 912. The lock spring 912 includes a plurality ofundulations 912 a, which cooperate to form a compression spring. Thelock spring 912 is compressible upon the application of an externalforce Fe to the plunger base 830 to move the plunger assembly 802 fromthe second, locked position to the first, unlocked position (FIG. 23).In one example, with reference to FIG. 23, the external force Fe is aforce applied to the plunger assembly 802 in a vertical direction tomove the plunger assembly 802 toward the first pump housing 800. Thus,the plunger assembly 802 is movable from the second, locked position(FIG. 24) to the first, unlocked position (FIG. 23) in a first direction(which is vertical in this example) and is movable in a second direction(counterclockwise) to dispense the fluid from the fluid reservoirs 810a, 810 b. The lock spring 912 exerts a spring force Fs2 (FIG. 24) in adirection toward a first end 800 a of the first pump housing 800 to biasthe plunger assembly 802 in the second, locked position. In the second,locked position, the teeth 915 a, 814 a engage, and inhibit a movementor rotation of the plunger assembly 802 relative to the reservoirs 810a, 810 b.

In one example, with reference to FIG. 20, in order to assemble the pump104, with the plunger base 830 formed and coupled to or integrallyformed with the plunger arms 832 a, 832 b, the plungers 884 are coupledto the second ends 898 of the respective plunger arms 832 a, 832 b. Withthe cannula 852 coupled to the cannula coupling portion 850, the cannulacoupling portion 850 is coupled to the plunger base 830. With the firstpump housing 800 formed, the lock spring 912 and the lock plate 910 arecoupled to the first pump housing 800. The torsion spring 804 is coupledto the first pump housing 800. The fluid reservoirs 810 a, 810 b arefilled with the fluid, such as insulin, and the plunger assembly 802 iscoupled to the first pump housing 800 such that the plungers 884 form aseal with the fluid reservoirs 810 a, 810 b to contain the fluid withinthe fluid reservoirs 810 a, 810 b.

With the pump 104 assembled, the pump 104 can be coupled to the wearableinfusion port 102 or the wearable infusion port 500 to supply therespective wearable infusion port 102 or the wearable infusion port 500with the fluid or insulin. In one example, with reference to FIG. 18,the pump 104 is coupled to the wearable infusion port 102. As thecannula 852 is positioned within the first needle port 132, the secondend 850 b of the cannula coupling portion 850 contacts the first surface110 a of the first housing 110. The contact between the cannula couplingportion 850 and the first surface 110 a creates the external force Fe,which overcomes the spring force Fs2 exerted by the lock spring 912 andcauses the lock plate 910 to move toward a first end 800 a of the firstpump housing 800 (FIG. 23). As the lock plate 910 moves towards thefirst end 800 a, the torsion spring 804 applies a force to the annularflange 835 to move or rotate the plunger assembly 802 relative to thefluid reservoirs 810 a, 810 b. When the lock plate 910 contacts asurface 800 b of the first pump housing 800, the plunger assembly 802(and the pump 104) is in the first, unlocked position (FIG. 23).

In the first, unlocked position, the torsion spring 804 applies thetorque to the annular flange 835 to drive, move or rotate the plungerassembly 802 relative to the first pump housing 800. The movement orrotation of the plunger assembly 802 causes the plunger arms 832 a, 832b to advance into the respective fluid reservoirs 810 a, 810 b. Theadvancement of the plunger arms 832 a, 832 b into the fluid reservoirs810 a, 810 b, in turn, causes an increase in pressure in the fluidreservoirs 810 a, 810 b, which with reference to FIG. 21, causes thefluid or insulin to flow through the inlet 906. The fluid or insulinflows from the inlet 906 into the respective body conduit 900, throughthe respective connector conduit 890, through the respective base branch838 a, 838 b, through the respective branch 856 a, 856 b (FIG. 20C),through into the cannula 852 and into the first needle port 132 of thewearable infusion port 102. Thus, the inlet 906, the body conduit 900and the connector conduit 890 of the respective plunger arm 832 a, 832 balong with the respective base branch 838 a, 838 b and the respectivebranch 856 a, 856 b cooperate to define an internal conduit of theplunger assembly 802 that cooperates to dispense the fluid containedwithin the respective fluid reservoir 810 a, 810 b into the cannula 852,and from the cannula 852, into the wearable infusion port 102. Dependingupon the volume that may be received by the wearable infusion port 102,500, the plunger arms 832 a, 832 b may advance within the respectivefluid reservoirs 810 a, 810 b until all of the fluid or insulincontained within the fluid reservoirs 810 a, 810 b is dispensed and theplungers 884 contact the second reservoir ends 816 of the respectivefluid reservoirs 810 a, 810 b as shown in FIG. 22.

With reference back to FIG. 18, once the selected amount of insulin hasbeen dispensed into the wearable infusion port 102, the user moves thepump 104 from the first surface 110 a of the first housing 110 of thewearable infusion port 102. The movement of the pump 104 from the firsthousing 110 removes the external force Fe created by the contact betweenthe cannula coupling portion 850 and the first housing 110, and thespring force Fs2 exerted by the lock spring 912 moves the lock plate 910relative to the surface 800 b of the first pump housing 800 to thesecond, locked position (FIG. 24) to fix the plunger assembly 802, andthus, the pump 104 in the second, locked position. In the second, lockedposition, fluid is inhibited from being dispensed by the pump 104.

Thus, the pump 104 enables a user to supply a fluid, such as insulin, toa wearable infusion port or other device in increments, which isbeneficial to users who require multiple fluid infusions over the courseof a day. Moreover, the pump 104 enables a user to carry multiple dosesof the fluid or insulin with them in a single housing, and eliminatesthe need to carry multiple syringes. It should be noted that while notshown herein, the pump 104 may be coupled to an adhesive patch, such asthe adhesive patch 122, and coupled to the anatomy as a patch pump.

While at least one exemplary embodiment has been presented in theforegoing detailed description, it should be appreciated that a vastnumber of variations exist. It should also be appreciated that theexemplary embodiment or embodiments described herein are not intended tolimit the scope, applicability, or configuration of the claimed subjectmatter in any way. Rather, the foregoing detailed description willprovide those skilled in the art with a convenient road map forimplementing the described embodiment or embodiments. It should beunderstood that various changes can be made in the function andarrangement of elements without departing from the scope defined by theclaims, which includes known equivalents and foreseeable equivalents atthe time of filing this patent application.

It should be understood that various aspects disclosed herein may becombined in different combinations than the combinations specificallypresented in the description and accompanying drawings. It should alsobe understood that, depending on the example, certain acts or events ofany of the processes or methods described herein may be performed in adifferent sequence, may be added, merged, or left out altogether (e.g.,all described acts or events may not be necessary to carry out thetechniques). In addition, while certain aspects of this disclosure aredescribed as being performed by a single module or unit for purposes ofclarity, it should be understood that the techniques of this disclosuremay be performed by a combination of units or modules associated with,for example, a medical device.

In one or more examples, the described techniques may be implemented inhardware, software, firmware, or any combination thereof. If implementedin software, the functions may be stored as one or more instructions orcode on a computer-readable medium and executed by a hardware-basedprocessing unit. Computer-readable media may include non-transitorycomputer-readable media, which corresponds to a tangible medium such asdata storage media (e.g., RAM, ROM, EEPROM, flash memory, or any othermedium that can be used to store desired program code in the form ofinstructions or data structures and that can be accessed by a computer).

Instructions may be executed by one or more processors, such as one ormore digital signal processors (DSPs), general purpose microprocessors,application specific integrated circuits (ASICs), field programmablelogic arrays (FPGAs), or other equivalent integrated or discrete logiccircuitry. Accordingly, the term “processor” as used herein may refer toany of the foregoing structure or any other physical structure suitablefor implementation of the described techniques. Also, the techniquescould be fully implemented in one or more circuits or logic elements.

What is claimed is:
 1. A pump for delivering a fluid, comprising: a pumphousing that defines at least one reservoir having a circumferentiallyopen first end, a circumferentially closed second end and a chamberdefined between the first end and the second end to receive the fluid;and a plunger assembly having at least one plunger arm and a cannulafluidly coupled to the at least one plunger arm to dispense the fluidfrom the pump, the at least one plunger arm receivable within the firstend of the at least one fluid reservoir, the at least one plunger armdefining an internal conduit to receive the fluid from the at least onefluid reservoir, the internal conduit is fluidly coupled to the cannula,and the plunger assembly is movable in a first direction relative to thepump housing to advance the at least one plunger arm within the at leastone fluid reservoir to dispense the fluid from the at least one fluidreservoir out of the pump via the cannula.
 2. The pump of claim 1,further comprising a biasing member coupled to the plunger assembly tomove the plunger assembly relative to the pump housing to dispense thefluid from the at least one fluid reservoir.
 3. The pump of claim 2,further comprising a lock system coupled to the pump housing between thepump housing and the plunger assembly, the lock system movable to movethe plunger assembly between a first, unlocked position in which theplunger assembly is movable relative to the pump housing to dispense thefluid and a second, locked position in which the plunger assembly isfixed relative to the pump housing.
 4. The pump of claim 3, wherein thelock system further comprises a lock plate and a lock biasing member,the lock plate coupled to the pump housing proximate the plungerassembly, the lock biasing member coupled between the lock plate and thepump housing, and the lock biasing member biases the lock plate intocontact with the plunger assembly in the second, locked position.
 5. Thepump of claim 4, wherein the plunger assembly is movable in a seconddirection relative to the pump housing to move the plunger assemblybetween the second, locked position and the first, unlocked position andthe second direction is different than the first direction.
 6. The pumpof claim 5, wherein the plunger assembly further comprises a plungerbase and a cannula coupling portion is coupled to the plunger base, thecannula coupling portion having a first end coupled to the pump housingand a second end coupled to the cannula, the second end extending adistance beyond a surface of the plunger base to receive a force to movethe plunger assembly in the second direction.
 7. The pump of claim 1,wherein the at least one fluid reservoir comprises a plurality of fluidreservoirs and the at least one plunger arm comprises a plurality ofplunger arms, the plurality of fluid reservoirs spaced apart about aperimeter of the pump housing and each plunger arm of the plurality ofplunger arms is movable within a respective one of the plurality offluid reservoirs to dispense the fluid from the respective one of theplurality of fluid reservoirs.
 8. The pump of claim 1, wherein the atleast one plunger arm includes a plunger to form a seal between the atleast one plunger arm and the at least one fluid reservoir, and theplunger defines an inlet in fluid communication with the internalconduit.
 9. The pump of claim 1, wherein the plunger assembly furthercomprises a plunger base, the at least one arm is coupled to a perimeterof the plunger base, the cannula is coupled proximate a center of theplunger base and a conduit is defined in the base to fluidly couple theinternal conduit to the cannula.
 10. The pump of claim 1, wherein thefluid is insulin and the pump is an insulin pump.